AFX ENDOVASCULAR AAA SYSTEM
FDA premarket approval P040002/S054 · decided 2015-06-17
Approval details
- PMA number
- P040002
- Supplement
- S054
- 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
- 2015-05-19
- Decision date
- 2015-06-17
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR UPDATES TO THE AFX INSTRUCTIONS FOR USE TO CLARIFY EXISTINGINFORMATION RELATED TO PROCEDURE PLANNING AND FOLLOW-UP IMAGING, AND TO IMPROVE THE INSTRUCTIONS FOR DELIVERY SYSTEM WITHDRAWAL OF THE AFX VELA PROXIMAL ENDOGRAFT.
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