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 | BIODIVYSIOI AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD, BUILDING G MAILING P.O. 9018 TEMECULA, CA 92590-9018 |
PMA Number | P000011 |
Supplement Number | S001 |
Date Received | 11/01/2000 |
Decision Date | 05/07/2001 |
Withdrawal Date
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09/05/2014 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE BIODIVYSIO(TM) AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM. |
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