AFX2 Endovascular AAA System
FDA premarket approval P040002/S071 · decided 2023-05-08
Approval details
- PMA number
- P040002
- Supplement
- S071
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- AFX2 Endovascular AAA System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2023-01-09
- Decision date
- 2023-05-08
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval of the protocol for the VQI and VISION EVAR Registry Analysis post-approval study (PAS) protocol.
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