Protege

Main information

  • Trade name:
  • Protege GPS Self - Expanding Peripheral Stent System - Multiple peripheral arteries stent
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Protege GPS Self - Expanding Peripheral Stent System - Multiple peripheral arteries stent
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218037
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218037

Medtronic Australasia Pty Ltd - Protege GPS Self - Expanding Peripheral Stent System - Multiple peripheral

arteries stent

ARTG entry for

Medical Device Included Class III

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

4/12/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

ev3 Inc

3033 Campus Drive

Plymouth, MN, 55441-2651

United States Of America

Products

1. Protege GPS Self - Expanding Peripheral Stent System - Multiple peripheral arteries stent

Product Type

Medical device system

Effective date

4/12/2013

GMDN

47932 Multiple peripheral arteries stent

Functional description

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.

Intended purpose

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.

Variant information

Diameter (mm) 6 - 14

Length (mm) 20 - 150

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 12:10:39 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information