Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p433
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 433/696)
Character Range: 15067506–15082103

Amplatzer Vascular Plug                                                                                                    Self expandable nitinol wire mesh                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Diameter 4mm - 16mm, Length 7 & 8mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                $1,268.00

     Inovanz (PTY) LTD
IZ002                                                                                      EOS Endoluminal Occlusion System                                                                                           EOS is made of self-expandable Nitinol flat wire, serving as a supportive scaffold with significant radial strength, covered by impermeable ePTFE membrane for achievement of immediate occlusion of a peripheral vessel. This implant is pre-loaded on a delivery catheter with 2 deployment handles. This System will be inserted through a standard guide catheter (not included) up to the targeted segment.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           3 to 5 mm of vessel diameter (6.1 mm diameter unconstrained)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       $1,268.00
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 4.5 to 8 mm of vessel diameter (9.1 mm diameter unconstrained)
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 7.5 to 11 mm of vessel diameter (12.2 mm diameter unconstrained)

     PENUMBRA NEURO AUSTRALIA PTY LTD
PN025                                                                                      Penumbra POD Packing Coil                                                                                                  Platinum coil designed in a WAVE shape to behave like a liquid to compliment the Plug effect of the POD and pack densely, reducing reliance on thrombus formation. This packing coil does not have the traditional 3D shape formation of other coils so only has a measurement of length                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   5cm length  15cm length  30cm length  45cm length  60cm length                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     $1,268.00
PN024                                                                                      Penumbra POD Occlusion Device                                                                                              The Peripheral Occlusion Device (POD) is compromised of a specifically designed platinum enbolisation coil with varied diameter and is attache to a composite pusher with a radiopaque positioning marker. The distal Anchor segment has a larger diameter to secure the coil in a straight or fast flowing vessel. The proximal segment has a softer and smaller diameter to ensure occlusion and stasis of the vessel. The device is transferred into the microcatheter and advanced under fluoroscopic guidance. The device may be fully deployed prior to detachment. the detachment handle is attached and advanced over the proximal ned of the delivery pusher and the the device is detached by using the retraction button on the handle for accurate placement                                                                                                                                                                                                                                                                                                   20cm Length - 3mm diameter  30cm Length - 3.25 - 4mm diameter  30cm Length - 4-5mm diameter  50cm Length - 5-6mm diameter  60cm Length - 6-8mm diameter  60cm Length - 8-10mm diameter  60cm Length - 10-12mm diameter  60cm Length - 12-14mm diameter                                                                                                                                                                                                                                                                                                                                                                                                                                             $1,268.00
PN020                                                                                      POD Packing Coil                                                                                                           POD Packing coil is a soft shapeless coil up to 60cm in length designed to pack very densely behind POD to occlude arteries and veins throughout the peripheral vasculature.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               15cm, 30cm, 45cm, 60cm lengths                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     $1,268.00

  ids (integral delivery system)
     ABBOTT MEDICAL AUSTRALIA PTY LTD.
SJ266                                                                                      AMPLATZER Vascular Plug - II                                                                                               The AMPLATZER Vascular Plug II is a self-expandable, multi-lobed cylindraical device made from a nitinol wire mesh.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        3mm-22mm Diameter, 6mm-18mm Plug Length                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            $1,895.00

  Microcatheter
     DIVERSE DEVICES PTY LTD
DL006                                                                                      IMPEDE Embolization Plug                                                                                                   The IMPEDE Embolization Plug is a pushable embolization device