AFX Endovascular AAA System
FDA premarket approval P040002/S065 · decided 2020-07-23
Approval details
- PMA number
- P040002
- Supplement
- S065
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFX Endovascular AAA System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2020-06-26
- Decision date
- 2020-07-23
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for an added destructive test to the process monitoring control for the AFX2 Bifurcated device.
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