|
Device | XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD, BUILDING G P.O.BOX 9018 TEMECULA, CA 92589-9018 |
PMA Number | P070015 |
Supplement Number | S116 |
Date Received | 10/24/2013 |
Decision Date | 11/20/2013 |
Withdrawal Date
|
04/26/2023 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF DRUG MATERIALS AT THE CLONMEL, IRELAND FACILITY AND A CONTRACT LABORATORY. |