- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S005
- Product code
- QWM
- Generic name
- Stent graft, bypass, superficial femoral artery
- Decision date
- 2025-09-18
- Decision code
- APPR
- Date received
- 2025-03-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Endologix, LLC at 3910 Brickway Blvd., Santa Rosa, CA 95403 for manufacturing the ENDOCROSS Device and associated manufacturing changes and for an alternate contract sterilizer for the ENDOCROSS Device located at Steris Isomedix Services at 43425 Business Park Drive, Temecula, CA 92590