Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p378
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 378/696)
Character Range: 13366139–13398209

1510 is also equipped with the RF wireless technology which enables remote monitoring of patients who have the Sorin SMARTVIEW Monitor installed at home and wireless interrogation and device programming by Orchestra Plus programmer equipped with ORCHESTRA PLUS LINK accessory. The PLATINIUM DR 1510 is designed to recognize and treat slow or fast VT and VF by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies. PLATINIUM DR 1510 features the PARAD/PARAD+ algorithm, which is specifically designed to differentiate ventricular tachycardias from fast rhythms of supraventricular origin. PARAD/PARAD+ continuously monitors R-R interval stability, searches for long cycles, assesses the degree of P-R association, evaluates sudden onset and determines the chamber of arrhythmia acceleration.                                                                                                                                                                                                                                                                                                                                               Dimensions 73 x 54.3 x 11.1 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $26,162.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Weight 86 g
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Volume 33 cm3
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Active surface area of casing 62.7cm2
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Connector Atrium: IS-1 bipolar. Ventricle: IS-1 bipolar, 2*DF-1.
QQ632                                                                                                                                                               Talentia 3510 DR                                                                                                                                       Dual chamber implantable cardioverter defibrillator                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Weight: 86g  Volume: 33cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      $26,162.00

  a,d,e
     ABBOTT MEDICAL AUSTRALIA PTY LTD.
SJ331                                                                                                                                                               Ellipse DR CD2377-36Q/CD2377-36QC                                                                                                                      Dual Chamber Cardioverter Defibrillator with 36J delivered energy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        68g, 31cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      $26,619.00
SJ325                                                                                                                                                               Fortify Assura DR CD2359-40Q/CD2359-40QC                                                                                                               Dual Chamber Cardioverter Defibrillator with 40J delivered energy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        75g, 35cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      $26,619.00

     BIOTRONIK AUSTRALIA PTY LIMITED
BT227                                                                                                                                                               Rivacor 7 DR-T                                                                                                                                         Dual Chamber ICD, ventricular capture control, physiological rate adaption, automatic event (IEGM) & trend triggered transmission. Wandless telemetry, Home Monitoring w/ QuickCheck, MRI conditional and AutoDetect, ComfortDesign DF4, IS-1 connector                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  66.5mm x 60mm x 10mm, 32cm3, 77grams                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           $26,619.00

     BOSTON SCIENTIFIC PTY LTD
BS339                                                                                                                                                               RESONATE EL DR DF-4                                                                                                                                    Dual Chamber implantable cardioverter defibrillation, 4IJ, DF-4 RV connector. ENDURALIFE Battery Technology and IMAGEREADY MR-Conditional                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                71.4g, 31.0cc, 5.37 x 7.68 x 0.99cm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            $26,619.00
BS277                                                                                                                                                               AUTOGEN ICD DR DF-4                                                                                                                                    Dual Chamber implantable cardioverter defibrillation, 4IJ, DF-4 RV connector                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             28.0cc - 31.0cc, 62.5g - 71.4g, 9.9mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          $26,619.00

     MICROPORT CRM PTY LIMITED
RF051                                                                                                                                                               Ulys™ DR 2540                                                                                                                                          MRI compatible dual chamber cardioverter defibrillator with DF-4 connector.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Weight - 86g  Volume - 33cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    $26,619.00
RF005                                                                                                                                                               Platinium DR 1540                                                                                                                                      PLATINIUM DR is an implantable dual-chamber cardioverter defibrillator. It is equipped with an accelerometer to allow adaptation of pacing to suit the patient's activity. PLATINIUM DR is also equipped with the RF wireless technology which enables remote monitoring of patients who have the Sorin SMARTVIEW Monitor installed at home, wireless interrogation and device programming by Orchestra Plus programmer equipped with ORCHESTRA PLUS LINK accessory. PLATINIUM DR provides high energy shocks (42 J) for enhanced safety, as well as automatic lead measurements to monitor system integrity.The PLATINIUM DR can serve as a defibrillation electrode (active housing) with a total surface area of 63 cm². The PLATINIUM DR is designed to recognize and treat slow or fast VT and VF by continuously monitoring atrial and