Alto Abdominal Stent Graft System
FDA premarket approval P120006/S039 · decided 2024-03-11
Approval details
- PMA number
- P120006
- Supplement
- S039
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Alto Abdominal Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2022-04-12
- Decision date
- 2024-03-11
- Days to decision
- 699 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- implementation of a change in PTFE resin used to manufacture the graft material of the Alto Abdominal Stent Graft System
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