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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 |
Date Received | 06/13/2011 |
Decision Date | 03/07/2012 |
Product Code |
NIP |
Docket Number | 12M-0221 |
Notice Date | 03/14/2012 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM. THIS DEVICE IS INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE NOVO OR RESTENOTIC LESIONS UP TO 180MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.5 -7.5MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S043 S044 S045 S046 S047 S048 S049 S050 S051 |