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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
3033 campus drive
plymouth, MN 55441
PMA NumberP110023
Supplement NumberS007
Date Received04/14/2014
Decision Date10/10/2014
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 14M-1599
Notice Date 10/24/2014
Advisory Committee Cardiovascular
Clinical Trials NCT01400919
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the everflex self-expanding peripheral stent system. This device is indicated for improving luminal diameter in patients with atherosclerotic disease in the common and/or external iliac arteries up to and including 100 mm in length, with a reference vessel diameter of 4. 5 to 7. 5 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling