PMA P040002S059
- Device
- AFX Endovascular AAA System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S059
- Product code
- MIH
- Decision date
- 2017-05-02
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for updates to the in-process inspection of the AFX2 Endovascular AAA System.
Current openFDA PMA Record#
- Device
- AFX Endovascular AAA System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S059
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2017-05-02
- Decision code
- APPR
- Date received
- 2017-04-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for updates to the in-process inspection of the AFX2 Endovascular AAA System.