AFX ENDOVASCULAR AAA SYSTEM
FDA premarket approval P040002/S046 · decided 2014-06-18
Approval details
- PMA number
- P040002
- Supplement
- S046
- Supplement type
- 135 Review Track For 30-Day Notice
- 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
- 2014-01-06
- Decision date
- 2014-06-18
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MODIFIED EPTFE GRAFT MANUFACTURING PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.