PMA P220021S003
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S003
- Product code
- QWM
- Decision date
- 2024-10-11
- Classification
- Cardiovascular
- Generic name
- Stent graft, bypass, superficial femoral artery
- Approval order statement
- approval of an alternative supplier for the braid component of the Delivery System
Current openFDA PMA Record#
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S003
- Product code
- QWM
- Generic name
- Stent graft, bypass, superficial femoral artery
- Decision date
- 2024-10-11
- Decision code
- OK30
- Date received
- 2024-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of an alternative supplier for the braid component of the Delivery System