|
Device | EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P110023 |
Supplement Number | S021 |
Date Received | 09/28/2016 |
Decision Date | 11/23/2016 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to decrease the sample size in the post-approval study protocol. |