|
Device | XIENCE PRIME AND XIENCE PRIME 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 | S009 |
Date Received | 01/24/2012 |
Decision Date | 09/14/2012 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL TO UPDATE THE PRODUCT LABELING CONTAINED IN THE INSTRUCTIONS FOR USE (IFU) AND PATIENT GUIDE FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND FOR THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THESE UPDATES SPECIFICALLY INCLUDED LONGER TERM FOLLOW-UP DATA TO ALLAPPLICABLE CLINICAL TRIALS FOR THE DEVICES. |