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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceLimFlow System
Generic NameStent graft, infrapopliteal, venous arterialization
ApplicantLimFlow, Inc.
3031 Tisch Way-110 Plaza West
San Jose, CA 95128
PMA NumberP220025
Date Received10/31/2022
Decision Date09/11/2023
Product Code QWN 
Advisory Committee Cardiovascular
Clinical TrialsNCT03970538
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for The LimFlow System. The device is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003