AFX2 Endovascular AAA System
FDA premarket approval P040002/S070 · decided 2022-12-06
Approval details
- PMA number
- P040002
- Supplement
- S070
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AFX2 Endovascular AAA System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2022-03-15
- Decision date
- 2022-12-06
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the updates to the AFX2 Endovascular AAA System labeling (i.e., Instructions For Use (IFU), patient guide, and implant card).
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