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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 NumberS002
Date Received05/16/2012
Decision Date06/14/2012
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Reduction of the uv intensity used to cure the bonding adhesive of the manifold sub- assembly process.
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