AFX Endovascular AAA System
FDA premarket approval P040002/S061 · decided 2018-08-09
Approval details
- PMA number
- P040002
- Supplement
- S061
- Supplement type
- Special (Immediate Track)
- 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
- 2018-07-10
- Decision date
- 2018-08-09
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for modifications to the AFX System Instructions for Use, specifically the inclusion of a sizing algorithm and clarification on device sizing guidelines.
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