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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.
 
DeviceMEDTRONIC AVE S7 ZIPPER MX CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP970035
Supplement NumberS043
Date Received10/18/2002
Decision Date10/28/2002
Withdrawal Date 10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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