|
Device | XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,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 | S063 |
Date Received | 01/31/2014 |
Decision Date | 07/03/2014 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00916370
|
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 TO REMOVE A STENT INSPECTION STEP. |
Post-Approval Study | Show Report Schedule and Study Progress |