AFX Endovascular AAA System
FDA premarket approval P040002/S060 · decided 2018-07-03
Approval details
- PMA number
- P040002
- Supplement
- S060
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AFX Endovascular AAA System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2018-04-02
- Decision date
- 2018-07-03
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for modifications to the Instructions for Use regarding general information for interventions through or re-interventions on an existing AFX device, as well as patient-tailored surveillance recommendations.
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