|
Device | XIENCE XPEDITION 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 | S043 |
Date Received | 04/17/2013 |
Decision Date | 07/15/2013 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL TO UPDATE THE LABELING FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT RAPID EXCHANGE (RX) SYSTEM TO REFLECT A 24-MONTH SHELF LIFE. |