AFX2 Endovascular AAA System
FDA premarket approval P040002/S073 · decided 2024-08-22
Approval details
- PMA number
- P040002
- Supplement
- S073
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFX2 Endovascular AAA System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2024-05-24
- Decision date
- 2024-08-22
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for use of an already approved site to serve as a secondary sterilization site for additional components and use of a new biological indicator.
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