|
Device | XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM- SV, AND LL |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110019 |
Supplement Number | S068 |
Date Received | 04/21/2014 |
Decision Date | 07/03/2014 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL TO CHANGE THE OUTER LAYER THICKNESS SPECIFICATION FOR THE INNER MEMBER CATHETER COMPONENT FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT OVER THE WIRE (OTW) SYSTEM. |