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 & 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 | S007 |
Date Received | 12/11/2006 |
Decision Date | 02/09/2007 |
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 MINOR MODIFICATIONS TO THE W-CREST PORTION OF BOTH MULTI-LINK VISION STENT SYSTEMS AS WELL AS A NON-LINEAR LINK SHIFT TO THE MEDIUM DESIGN MULTI-LINK VISION CORONARY STENT SYSTEM. |
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