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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.
DeviceDETOUR System
Generic NameStent graft, bypass, superficial femoral artery
ApplicantEndologix, LLC
3910 Brickway Blvd
Santa Rosa, CA 95403
PMA NumberP220021
Date Received10/11/2022
Decision Date06/07/2023
Product Code QWM 
Docket Number 23M-2414
Notice Date 06/14/2023
Advisory Committee Cardiovascular
Clinical TrialsNCT03119233
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the DETOUR System for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001