DETOUR System
FDA premarket approval P220021/S002 · decided 2025-02-14
Approval details
- PMA number
- P220021
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- DETOUR System
- Generic name
- Stent graft, bypass, superficial femoral artery
- Applicant
- Endologix, LLC
- Date received
- 2024-08-29
- Decision date
- 2025-02-14
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- QWM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for post-approval labeling update to include the most recent clinical data from the DETOUR System.
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