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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceEVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
MEDTRONIC VASCULAR INC
3033 campus drive
plymouth, MN 55441
PMA NumberP110023
Date Received06/13/2011
Decision Date03/07/2012
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 12M-0221
Notice Date 03/14/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00530712
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
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 
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