|
Device | S660 2.75 WITH DISCRETE TECHNOLOGY OTW CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P970035 |
Supplement Number | S032 |
Date Received | 11/14/2001 |
Decision Date | 01/31/2002 |
Withdrawal Date
|
10/18/2010 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MEDTRONIC AVE S660 2.75 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE TREATMENT OF ACUTE OR THREATENED CLOSURE DURING A PLANNED INTERVENTIONAL PROCEDURE IN DE NOVO LESIONS (<=24 MM IN LENGTH) IN NATIVE CORONARY ARTERY OR ARTERIAL BYPASS GRAFT CONDUIT WITH A REFERENCE DIAMETER BETWEEN 2.2 MM AND 2.9 MM. LONG-TERM OUTCOME (BEYOND 30 DAYS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT. |