|
Device | GFX-XP/GFX2 CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P970035 |
Supplement Number | S008 |
Date Received | 10/08/1998 |
Decision Date | 04/08/1999 |
Withdrawal Date
|
10/18/2010 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 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. |