DETOUR System
FDA premarket approval P220021/S008 · decided 2025-12-23
Approval details
- PMA number
- P220021
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DETOUR System
- Generic name
- Stent graft, bypass, superficial femoral artery
- Applicant
- Endologix, LLC
- Date received
- 2025-11-26
- Decision date
- 2025-12-23
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- QWM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- implementation of new semi-automated crimping equipment and an in-process verification test during manufacturing of the TORUS SG
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