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 | MULTI-LINK RX PIXEL/OTW PIXEL CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD TEMECULA, CA 92591 |
PMA Number | P970020 |
Supplement Number | S041 |
Date Received | 02/15/2002 |
Decision Date | 06/28/2002 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR INCLUSION OF SIX-MONTH TRIAL DATA IN THE INSTRUCTIONS FOR USE BOOKLET FOR THE MULTI-LINK RX AND OTW TETRA CORONARY STENT SYSTEMS. |
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