AFX ENDOVASCULAR AAA SYSTEM
FDA premarket approval P040002/S045 · decided 2014-02-06
Approval details
- PMA number
- P040002
- Supplement
- S045
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFX ENDOVASCULAR AAA SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2013-12-17
- Decision date
- 2014-02-06
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF A CONTRACT STERILIZER LOCATED AT STERIS-ISOMEDIX SERVICES, IN TEMECULA, CALIFORNIA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.