Alto Abdominal Stent Graft System
FDA premarket approval P120006/S044 · decided 2024-09-27
Approval details
- PMA number
- P120006
- Supplement
- S044
- Supplement type
- 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
- 2024-08-30
- Decision date
- 2024-09-27
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- implementation of a revised ethylene oxide sterilization cycle at one of the sterilization sites and use of a new biological indicator
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