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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 NumberS001
Date Received09/15/2023
Decision Date10/12/2023
Product Code QWN 
Advisory Committee Cardiovascular
Clinical TrialsNCT05313165
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220025.
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