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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGFX-XP/GFX2 CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
PMA NumberP970035
Supplement NumberS008
Date Received10/08/1998
Decision Date04/08/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Medtronic AVE GFX(R) 2 Over-The-Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length < 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 mm to 4.0 mm. Long term outcome (beyond six months) for this permanent implant is unknown at present.
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