DETOUR System
FDA premarket approval P220021 · decided 2023-06-07
Approval details
- PMA number
- P220021
- Trade name
- DETOUR System
- Generic name
- Stent graft, bypass, superficial femoral artery
- Applicant
- Endologix, LLC
- Date received
- 2022-10-11
- Decision date
- 2023-06-07
- Days to decision
- 239 days
- Decision code
- APPR
- Product code
- QWM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- 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.
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