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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
ApplicantEV3 INC.
PMA NumberP110023
Supplement NumberS012
Date Received08/22/2014
Decision Date04/29/2015
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Clinical Trials NCT02066740
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add the 5f entrust otw delivery system. The device, as modified, will be marketed under the trade name everflex self-expanding peripheral stent with entrust delivery system and is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140mm in length in the native superficial femoral artery (sfa) and/or proximal popliteal arteries with reference vessel diameters ranging from 4. 5-7. 5mm.