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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 Dr.
Plymouth, MN 55441
PMA NumberP110023
Supplement NumberS068
Date Received06/26/2026
Decision Date07/10/2026
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the fixture used with the Branson Ultrasonic Welder and manifold inspection associated with this process.
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