Summary for ARTG Entry:
St Jude Medical Australia Pty Ltd - HeartMate II Sealed Inflow Conduit - Implantable ventricular circulatory
assist system inflow cannula, animal-derived
ARTG entry for
Medical Device Included Class III
St Jude Medical Australia Pty Ltd
17 Orion Road,LANE COVE, NSW, 2066
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
6035 Stoneridge Drive
Pleasanton, CA, 94588
United States Of America
1. HeartMate II Sealed Inflow Conduit - Implantable ventricular circulatory assist system inflow cannula,
Single Device Product
61749 Implantable ventricular circulatory assist system inflow cannula, animal-derived
The sealed inflow conduit of the pump is attached to the apex of the left ventricle and the pump sealed
outflow graft is connected to the ascending aorta. The sealed inflow conduit and outflow elbows have a
textured titanium microsphere surface.
Intended as a component of a ventricular circulatory assist system for haemodynamic support to patients
with end stage refactory left ventricular heart failure.
Nil variant (as 1 device) Nil
No Specific Conditions included on Record
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