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 | BIODIVYSIO OC/OTW STENT 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 | S004 |
Date Received | 08/31/2001 |
Decision Date | 03/01/2002 |
Withdrawal Date
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09/05/2014 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE BIODIVYSIO OC OTW IN 11 MM, 15 MM, 18 MM, 22 MM AND 28 MM STENT LENGTHS AND 3.0 MM, 3.5 MM AND 4.0 MM DIAMETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO OC OTW AND IS INDICATED FOR: "USE IN SUBJECTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >= 3.0 MM TO <= 4.0 MM AND INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER. LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT." |
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