DETOUR System
FDA premarket approval P220021/S004 · decided 2025-03-03
Approval details
- PMA number
- P220021
- Supplement
- S004
- 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
- 2025-02-07
- Decision date
- 2025-03-03
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- QWM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- approval for processing changes to the outer shaft of the stent graft delivery system
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