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. |
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Device | MEDTRONIC AVE S7 ZIPPER MX CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P970035 |
Supplement Number | S043 |
Date Received | 10/18/2002 |
Decision Date | 10/28/2002 |
Withdrawal Date
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10/18/2010 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF TWO NEW INDICATIONS FOR THE MEDTRONIC AVE S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM, SPECIFICALLY FOR DIRECT STENTING AND FOR THE TREATMENT OF SAPHENOUS VEIN GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC AVE S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM AND 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 AND SAPHENOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM USING DIRECT STENTING OR PRE-DILATATION. LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. |
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