AFX ENDOVASCULAR AAA SYSTEM
FDA premarket approval P040002/S040 · decided 2012-12-28
Approval details
- PMA number
- P040002
- Supplement
- S040
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFX ENDOVASCULAR AAA SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2012-11-08
- Decision date
- 2012-12-28
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF BIFURCATED STENT GRAFT MODELS FOR THE APPROVED AFX ENDOVASCULAR AAA SYSTEM PRODUCT FAMILY. THE NEW MODELS CONTAIN SHORTER AND LONGER BIFURCATED BODIES THAT WILL HAVE THE SAME DIAMETER AS THOSE CURRENTLY APPROVED; AND TO ADD 20MM DIAMETER LIMBS USING THE SAME STENT CAGE.
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