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 CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR P.O. BOX 9018 TEMECULA, CA 92589-9018 |
PMA Number | P020047 |
Supplement Number | S042 |
Date Received | 02/03/2012 |
Decision Date | 04/03/2012 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE MULTI-LINK 8 CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) TO ALIGN/UPDATE THE IFU VERBIAGE WITH A RECENTLY APPROVED CORONARY STENT SYSTEM. |
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