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 VISION CORONARY STENT SYSTEM AND MULTI-LINK MINI VISION CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR P.O. BOX 9018 TEMECULA, CA 92589-9018 |
PMA Number | P020047 |
Supplement Number | S010 |
Date Received | 09/10/2007 |
Decision Date | 10/26/2007 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR, GALWAY, IRELAND. |
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