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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, LimFlow Crossing Stent Graft and LimFLow Extension Stent Graft
Generic NameStent graft, infrapopliteal, venous arterialization
ApplicantLimFlow, Inc.
3031 Tisch Way - 110 Plz. W.
San Jose, CA 95128
PMA NumberP220025
Supplement NumberS005
Date Received01/02/2025
Decision Date02/12/2025
Product Code QWN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a minor design modification to the button lock
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