DETOUR System
FDA premarket approval P220021/S006 · decided 2025-10-09
Approval details
- PMA number
- P220021
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DETOUR System
- Generic name
- Stent graft, bypass, superficial femoral artery
- Applicant
- Endologix, LLC
- Date received
- 2025-08-28
- Decision date
- 2025-10-09
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- QWM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- a manufacturing site located at Endologix, LLC at 3910 Brickway Blvd., Santa Rosa, CA 95403 for manufacturing the TORUS Stent Graft System and associated manufacturing changes and for an alternate contract sterilizer for the TORUS Stent Graft System located at Steris Isomedix Services at 43425 Business Park Drive, Temecula, CA 92590
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