PMA P220021S004
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S004
- Product code
- QWM
- Decision date
- 2025-03-03
- Classification
- Cardiovascular
- Generic name
- Stent graft, bypass, superficial femoral artery
- Approval order statement
- approval for processing changes to the outer shaft of the stent graft delivery system
Current openFDA PMA Record#
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S004
- Product code
- QWM
- Generic name
- Stent graft, bypass, superficial femoral artery
- Decision date
- 2025-03-03
- Decision code
- OK30
- Date received
- 2025-02-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for processing changes to the outer shaft of the stent graft delivery system