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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 NumberS006
Date Received02/03/2014
Decision Date06/22/2014
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Clinical Trials NCT00530712
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updated labeling that includes 3-year clinical outcomes.
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