PMA P040002S065
- Device
- AFX Endovascular AAA System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S065
- Product code
- MIH
- Decision date
- 2020-07-23
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for an added destructive test to the process monitoring control for the AFX2 Bifurcated device.
Current openFDA PMA Record#
- Device
- AFX Endovascular AAA System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S065
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-07-23
- Decision code
- APPR
- Date received
- 2020-06-26
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an added destructive test to the process monitoring control for the AFX2 Bifurcated device.