PMA P220021S008
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S008
- Product code
- QWM
- Decision date
- 2025-12-23
- Classification
- Cardiovascular
- Generic name
- Stent graft, bypass, superficial femoral artery
- Approval order statement
- implementation of new semi-automated crimping equipment and an in-process verification test during manufacturing of the TORUS SG
Current openFDA PMA Record#
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S008
- Product code
- QWM
- Generic name
- Stent graft, bypass, superficial femoral artery
- Decision date
- 2025-12-23
- Decision code
- OK30
- Date received
- 2025-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of new semi-automated crimping equipment and an in-process verification test during manufacturing of the TORUS SG