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 8, MULTI-LINK 8 SV AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (CSS) |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR P.O. BOX 9018 TEMECULA, CA 92589-9018 |
PMA Number | P020047 |
Supplement Number | S053 |
Date Received | 11/09/2012 |
Decision Date | 12/05/2012 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A SECOND STERILIZATION CHAMBER IN IRELAND. |
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