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 | PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO OPEN CELL (OC) STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) 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 | S009 |
Date Received | 07/01/2003 |
Decision Date | 12/08/2003 |
Withdrawal Date
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09/05/2014 |
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 THE ADDITION OF AN 8 MM STENT IN DIAMETERS OF 3.0, 3.5, AND 4.0 MM FOR THE BIODIVYSIO OC OTW SYSTEM. |
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