PMA P220021S002
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S002
- Product code
- QWM
- Decision date
- 2025-02-14
- Classification
- Cardiovascular
- Generic name
- Stent graft, bypass, superficial femoral artery
- Approval order statement
- Approval for post-approval labeling update to include the most recent clinical data from the DETOUR System.
Current openFDA PMA Record#
- Device
- DETOUR System
- Applicant
- Endologix, LLC
- PMA number
- P220021
- Supplement
- S002
- Product code
- QWM
- Generic name
- Stent graft, bypass, superficial femoral artery
- Decision date
- 2025-02-14
- Decision code
- APPR
- Date received
- 2024-08-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for post-approval labeling update to include the most recent clinical data from the DETOUR System.