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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.
 
Trade NameEVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM
Classification Namestent, superficial femoral artery
ApplicantEV3 INC.
PMA NumberP110023
Supplement NumberS010
Date Received07/10/2014
Decision Date09/03/2014
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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