PMA P220021
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- Product code
- QWM
- Decision date
- 2026-01-22
- Generic name
- Stent graft, bypass, superficial femoral artery
- Approval order statement
- changes to the stent graft lot release testing and criteria
Current openFDA PMA Record#
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S007
- Product code
- QWM
- Generic name
- Stent graft, bypass, superficial femoral artery
- Decision date
- 2026-01-22
- Decision code
- APPR
- Date received
- 2025-09-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the stent graft lot release testing and criteria