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 | S7 WITH DISCRETE TECHNOLOGY (TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P970035 |
Supplement Number | S029 |
Date Received | 08/14/2001 |
Decision Date | 10/04/2001 |
Withdrawal Date
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10/18/2010 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE (OTW) AND RAPID EXCHANGE (RX) CORONARY STENT SYSTEMS USING THE AV100 BALLOON MATERIAL. (NOTE THAT ALTHOUGH THIS MATERIAL WAS INCLUDED IN PRODUCT USED IN THE CLINICAL TRIAL REPORTED IN SUPPLEMENT 22, APPROVAL WAS ONLY SOUGHT AND GRANTED FOR THE AV2000 BALLOON MATERIAL.) |
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