| 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. |
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| Device | DETOUR System |
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| Generic Name | Stent graft, bypass, superficial femoral artery |
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| Applicant | Endologix, LLC
3910 Brickway Blvd
Santa Rosa, CA 95403 |
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| PMA Number | P220021 |
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| Date Received | 10/11/2022 |
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| Decision Date | 06/07/2023 |
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| Product Code |
QWM |
| Docket Number | 23M-2414 |
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| Notice Date | 06/14/2023 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT03119233
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 |
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|
