|
Device | XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110019 |
Supplement Number | S084 |
Date Received | 03/16/2016 |
Decision Date | 04/15/2016 |
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 Change the sampling plan for annual stability of the repackaged drug substance. |