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 FAMILY OF CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD TEMECULA, CA 92591 |
PMA Number | P970020 |
Supplement Number | S033 |
Date Received | 05/07/2001 |
Decision Date | 06/01/2001 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A REPLACEMENT WHITE FOIL MARKER MATERIAL ON THE FOLLOWING FAMILY OF CORONARY STENT SYSTEMS: MULTI-LINK TET, MULTI-LINK ULTR, MULTI-LINK PENTA AND MULTI-LINK PIX (CURRENTLY UNDER REVIEW). |
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