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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.
 
DeviceLimFlow System
Generic NameStent graft, infrapopliteal, venous arterialization
ApplicantLimFlow, Inc.
3031 Tisch Way - 110 Plz. W.
San Jose, CA 95128
PMA NumberP220025
Supplement NumberS008
Date Received12/12/2025
Decision Date01/07/2026
Product Code QWN 
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  
a manufacturing process change for the soft tip bond
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