PMA P220021S001
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S001
- Product code
- QWM
- Decision date
- 2023-08-09
- Classification
- Cardiovascular
- Generic name
- Stent graft, bypass, superficial femoral artery
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S001
- Product code
- QWM
- Generic name
- Stent graft, bypass, superficial femoral artery
- Decision date
- 2023-08-09
- Decision code
- APPR
- Date received
- 2023-07-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.