AFX ENDOVASCULAR AAA SYSTEM
FDA premarket approval P040002/S035 · decided 2011-12-06
Approval details
- PMA number
- P040002
- Supplement
- S035
- 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
- 2011-11-01
- Decision date
- 2011-12-06
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MODIFIED CONTRALATERAL LIMB SUREPASS GUIDEWIRE HOLDER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX AAA ENDOVASCULAR SYSTEM AND IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA.
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