AFX ENDOVASCULAR AAA DELIVERY SYSTEM
FDA premarket approval P040002/S042 · decided 2013-08-26
Approval details
- PMA number
- P040002
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFX ENDOVASCULAR AAA DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2013-07-05
- Decision date
- 2013-08-26
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF NEW GUIDEWIRE SUBASSEMBLY PROVIDED BY ACME MONACO.
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