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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC AVE S7 ZIPPER MX CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC AVE, INC.
PMA NumberP970035
Supplement NumberS043
Date Received10/18/2002
Decision Date10/28/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
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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