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 AS OTW |
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 | S005 |
Date Received | 09/24/2001 |
Decision Date | 10/22/2001 |
Withdrawal Date
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09/05/2014 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement AMENDING EXISTING PROCEDURES TO IMPROVE THE INSPECTION OF STENTS AFTER LASER CUTTING, PRIOR TO AND AFTER ELECTROPOLISHING; AND ADDITION OF THE UNIVERSAL STENT CRIMPER. |
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