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Device | EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P110023 |
Supplement Number | S006 |
Date Received | 02/03/2014 |
Decision Date | 06/22/2014 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR UPDATED LABELING THAT INCLUDES 3-YEAR CLINICAL OUTCOMES. |
Post-Approval Study | Show Report Schedule and Study Progress |