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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantMEDTRONIC VASCULAR INC
3033 Campus Drive
Plymouth, MN 55441
PMA NumberP110023
Date Received06/13/2011
Decision Date03/07/2012
Product Code NIP 
Docket Number 12M-0221
Notice Date 03/14/2012
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow 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 
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