Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p371
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 371/696)
Character Range: 13174490–13208651

MRI models                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          33cm³ 77g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      $23,920.00
MI394                                                                                                                                                               Cobalt™ XT VR ICD MRI SureScan™                                                                                                                        Single Chamber Implantable Cardioverter Defibrillator with PhysionCurve Design, MRI compatible, Optimised Battery Chemistry, SmartShock 2.0+ Technology, Optivol 2.0 Fluid Status Monitoring, Complete Capture Management, BlueSync technology, DF1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      33.2 cm3, 79 g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $23,920.00
MI255                                                                                                                                                               VISIA AF XT ICDs/ VISIA AF MRI XT SureScan ICDs                                                                                                        Digital single chamber implantable cardioverter defibrillator. PhysioCurve™ Design, SmartShock™ Technology, OptiVol™ 2.0 Fluid Status Monitoring, Complete Capture Management™ Diagnostic (RVCM), AF Diagnostics including SureScan/ MRI models                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          33cm³ 77g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      $23,920.00
MI114                                                                                                                                                               Evera MRI S VR SureScan DF1                                                                                                                            Single Chamber Implantable Cardioverter Defibrillator with PhysioCurve Design, Optimised Battery Chemistry, Smart Shock Technology 2.0, DF1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              33cm³ 77g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      $23,920.00
MI386                                                                                                                                                               Cobalt™ VR ICD MRI SureScan™                                                                                                                           Single Chamber Implantable Cardioverter Defibrillator with PhysionCurve Design, MRI compatible, Optimised Battery Chemistry, SmartShock 2.0 Technology, Complete Capture Management, BlueSync technology, DF1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            33.2 cm3, 79 g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $23,920.00
MI385                                                                                                                                                               Crome™ VR ICD MRI SureScan™                                                                                                                            Single Chamber Implantable Cardioverter Defibrillator with PhysionCurve Design, MRI compatible, Optimised Battery Chemistry, SmartShock 2.0 Technology, Complete Capture Management, BlueSync technology, DF1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            33.2 cm3, 79 g                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 $23,920.00

     MICROPORT CRM PTY LIMITED
RF001                                                                                                                                                               Platinium VR 1210                                                                                                                                      PLATINIUM VR  is an implantable single-chamber cardioverter defibrillator. It is equipped with an accelerometer to allow adaptation of pacing to suit the patient's activity. PLATINIUM VR 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 VR provides high energy shocks (42 J) for enhanced safety, as well as automatic lead measurements to monitor system integrity. PLATINIUM VR is protected against high-frequency signals emitted by cellular telephones. The PLATINIUM VR ICD device and programming system. The programming system includes the Sorin dedicated programmer with the SMARTVIEW programming software connected to a CPR3 programming head. The programming system is configured and furnished by Sorin. The PLATINIUM VR can serve as a defibrillation electrode (active housing) with a total surface area of 63 cm2. PLATINIUM VR 1210 has two DF-1 and one IS-1 connector ports. The PLATINIUM VR is designed to recognize and treat slow or fast VT and VF by continuously monitoring ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies. PLATINIUM VR features DISCRIMINATION algorithm.                                      Dimensions 73 x 54.3 x 11.1mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  $23,920.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Weight 85 g
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Volume 33 cm3
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Active surface area of casing 62.7cm2
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Connector IS-1 bipolar, 2*DF-1.
RF052                                                                                                                                                               ULYS™  VR 2210                                                                                                                                         Single chamber implantable cardioverter defibrillator                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Weight - 85g  Volume - 33cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    $23,920.00
QQ631                                                                                                                                                               Talentia VR 3210                                                                                                                                       Single chamber implantable cardioverter defibrillator                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Weight - 85g Volume - 33cc                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     $23,920.00

  a, d, e
     ABBOTT MEDICAL AUSTRALIA PTY LTD.
SJ318                                                                                                                                                               Fortify Assura VR CD1359-40Q/CD1359-40QC                                                                                                               Single