Identity
- Trade Name
- DETOUR System FDA PMA
- Generic Name
- Stent graft, bypass, superficial femoral artery FDA PMA
Identifiers
- PMA Number
- P220021 FDA PMA
- FDA Product Code
- QWM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The DETOUR System is a stent graft bypass designed for the superficial femoral artery. It is indicated for percutaneous revascularization in patients with symptomatic femoropopliteal lesions ranging from 200 mm to 460 mm in length, including chronic total occlusions (100 mm to 425 mm) or diffuse stenosis greater than 70%.
It is supplied as a percutaneous endovascular device for use in patients who may be suboptimal candidates for surgical or alternative endovascular treatments. The system is not for use in coronary or cerebral vasculature. Authorization is based on FDA PMA approval (P220021), and it is a Class III device.
Frequently asked questions
What is the DETOUR System used for?
The DETOUR System is used for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length, including chronic total occlusions (100 mm to 425 mm) or diffuse stenosis greater than 70%, in patients who may be suboptimal candidates for surgical or alternative endovascular treatments.
Is the DETOUR System approved for use in coronary or cerebral arteries?
No, the DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature, as explicitly stated in the approval documentation.
What regulatory pathway was used for the DETOUR System?
The DETOUR System received approval through the FDA Premarket Approval (PMA) pathway, with PMA number P220021 and decision date of June 7, 2023.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P220021 | Class III | Active |
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Manufacturer
- Manufacturer
- Endologix LLC
- FDA Applicant
- Endologix, LLC
Sources (1)
- FDA PMA P220021 24 fields · synced Oct 6, 2026