AFX ENDOVASCULAR AAA SYSTEM
FDA premarket approval P040002/S031 · decided 2011-05-06
Approval details
- PMA number
- P040002
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFX ENDOVASCULAR AAA SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2010-12-16
- Decision date
- 2011-05-06
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A NEW EPTFE GRAFT PROCESS AS WELL AS CHANGES TO THE DELIVERY SYSTEM.
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