Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p388
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 388/696)
Character Range: 13649253–13705443

Single Chamber Pacemakers
08.04.03 - SSIR with small/compact size, multi-programmability & longevity, & four or more advanced features
     MEDTRONIC AUSTRALASIA PTY LTD
MI246                                                                                                                                                               Azure XT SR MRI SureScan                                                                                                                               MR Conditional single chamber pacemaker with SureScan™ technology and Bluetooth® wireless telemetry (OOE-VVIR)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           12.25cm3 22.5g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $3,662.00
MI223                                                                                                                                                               Azure S SR MRI SureScan                                                                                                                                MR Conditional single chamber pacemaker with SureScan™ technology and Bluetooth® wireless telemetry (OOE-VVIR)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           12.25cm3 22.5g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $3,662.00
MI228                                                                                                                                                               Attesta SR MRI SureScan pacemaker                                                                                                                      MRI, single chamber rate responsive pacemaker (AAIR/VVIR, AAI/VVI)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       9.7cm3 21.5g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   $3,662.00
MI161                                                                                                                                                               Advisa SR MRI SureScan pacemaker A3SR01                                                                                                                Single chamber pacemaker with SureScan MRI Technology                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    11.9cm3 21g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    $3,662.00
MC728                                                                                                                                                               Adapta Pacemaker                                                                                                                                       SR Pacemaker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             9.7 - 11.0cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   $3,662.00
                                                                                                                                                                                                                                                                                                                           Models ADSR01, ADSR06, ADSR03                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            21.5 - 22.5g

     MICROPORT CRM PTY LIMITED
RF031                                                                                                                                                               ENO SR                                                                                                                                                 Single Chamber MRI Conditional Pacemaker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Weight -19g  Volume 7.5cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      $3,662.00
RF012                                                                                                                                                               KORA 100 SR                                                                                                                                            KORA 100 SR is a Single Chamber MRI conditional rate-responsive pacemaker.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Dimensions 37.4 x 41.5 x 6.1mm,  Weight 19g. Volume 7.5cm3. Connector IS-1. Sensors Minute Ventilation (MV) and Accelerometer (G).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             $3,662.00
RF028                                                                                                                                                               TEO SR                                                                                                                                                 Single Chamber MRI Conditional Pacemaker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Weight - 19g  Volume- 7.5cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    $3,662.00
RF043                                                                                                                                                               Alizea™ SR                                                                                                                                             Single Chamber MRI Conditional Pacemaker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Volume - 10.5cc    Weight -23.3g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               $3,662.00
RF027                                                                                                                                                               OTO SR                                                                                                                                                 Single Chamber MRI Conditional Pacemaker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Weight- 19g  Volume - 7.5cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    $3,662.00

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     ABBOTT MEDICAL AUSTRALIA PTY LTD.
SJ363                                                                                                                                                               Assurity MRI PM1272                                                                                                                                    MRI Conditional RF Single Chamber Rate Responsive Pacemaker                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              10.4cc, 20g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    $3,662.00
SJ365                                                                                                                                                               Endurity MRI PM1172                                                                                                                                    MR Conditional Single Chamber Pacing System                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              9.7cc, 19g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     $3,662.00

     BIOTRONIK AUSTRALIA PTY LIMITED
QQ139                                                                                                                                                               Solvia Rise SR-T                                                                                                                                       Single Chamber Pacemaker, ventricular capture control, physiological rate adaption,                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      48 x 40  x 6.5 mm,  10cm3   20.8g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              $3,662.00
                                                                                                                                                                                                                                                                                                                           automatic event (IEGM) & trend triggered transmission. Wandless telemetry, Home
                                                                                                                                                                                                                                                                                                                           Monitoring, MRI Guard 24/7, Closed Loop Stimulation, IS-1 connector
QQ134                                                                                                                                                               Amvia Sky SR-T                                                                                                                                         Single Chamber Pacemaker, ventricular capture control, physiological rate adaption, Quick/Early Check, automatic event (IEGM) & trend triggered transmission. Wandless telemetry, Home Monitoring, MRI Guard 24/7, Closed Loop Stimulation, IS-1 connector                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               48 x 40 x 6.5 mm, 10 cm3 , 20.8 grams                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          $3,662.00
BT203                                                                                                                                                               Edora 8 SR-T                                                                                                                                           Single Chamber Pacemaker, ventricular capture control, physiological rate adaption, automatic event (IEGM) & trend triggered transmission. Wandless telemetry, Home Monitoring, MRI AutoDect, MRI conditional, IS-1 connector                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            48 x 40 x 6.5 mm, 10 cm3 , 20.8 grams                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          $3,662.00
BT215                                                                                                                                                               Evity 8 SR-T                                                                                                                                           Single Chamber Pacemaker, ventricular capture control, physiological rate adaption, automatic event (IEGM) & trend triggered transmission. Wandless telemetry, Home Monitoring, MRI AutoDect, MRI conditional, IS-1 connector                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            IS-1 (1x)   10 cm3/ 20.8g     48 mm × 40 mm × 6.5 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           $3,662.00

     BOSTON SCIENTIFIC PTY LTD
BS271                                                                                                                                                               VITALIO MRI SR                                                                                                                                         Single Chamber Pacemaker, MRI Compatible                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 11.5cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         $3,662.00
BS320                                                                                                                                                               ACCOLADE MRI SR                                                                                                                                        Single Chamber Pacemaker, MRI Conditional                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                ACCOLADE MRI SR 4.45 x