|
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 | S119 |
Date Received | 12/23/2013 |
Decision Date | 05/29/2014 |
Withdrawal Date
|
04/26/2023 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A CHANGE IN THE RESIN COMPOSITION OF POLYPROPYLENE SUPPLY ITEMS USED IN XIENCE PRIMER AND DRUG FORMULATION MANUFACTURING. |