|
Device | SUPERA PERIPHERAL STENT SYSTEM |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P120020 |
Supplement Number | S011 |
Date Received | 08/10/2015 |
Decision Date | 01/22/2016 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00933270
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A POST-APPROVAL STUDY PROTOCOL. |