Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Protege GPS Self - Expanding Peripheral Stent System - Multiple peripheral
ARTG entry for
Medical Device Included Class III
Medtronic Australasia Pty Ltd
PO Box 945,NORTH RYDE BC, NSW, 1670
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.
3033 Campus Drive
Plymouth, MN, 55441-2651
United States Of America
1. Protege GPS Self - Expanding Peripheral Stent System - Multiple peripheral arteries stent
Medical device system
47932 Multiple peripheral arteries stent
The Protege GPS Self Expanding Peripheral Stent is a self expanding stent intended for permanent
implantation. The stent is made of a nickel-titanium alloy (Nitinol) and comes premounted on a 6F
over-the-wire delivery system. The Delivery System is comprised of an inner shaft and outer sheath which
are locked together with a safety lock.
The system as supplied includes the stent, the delivery catheter, the stent delivery system, stopcock and
tubing for flushing.
The Protege GPS Self-Expanding stent is indicated for use in occlusions, lesions at high risk for abrupt
closure or threatened closure following percutaneous transluminal angioplasty (PTA); or lesions believed
to be at high risk for restenosis following PTA in the common iliac, external iliac or subclavian arteries.
Stenting is intended to improve and maintain artery luminal diameter.
Diameter (mm) 6 - 14
Length (mm) 20 - 150
No Specific Conditions included on Record
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