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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEVERFLEX SELF EXPANDING PERIPHERAL STENT SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantMEDTRONIC VASCULAR INC
3033 Campus Drive
Plymouth, MN 55441
PMA NumberP110023
Supplement NumberS011
Date Received07/21/2014
Decision Date08/20/2014
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE MANUAL PROCESS FOR MEASURING STENT DIMENSIONS TO AN AUTOMATED PROCESS.
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