PMA P040002S066
- Device
- AFX Endovascular AAA System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S066
- Product code
- MIH
- Decision date
- 2020-08-05
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Manufacturing process changes related to the AFX2 implant loading procedure into the delivery system.
Current openFDA PMA Record#
- Device
- AFX Endovascular AAA System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S066
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-08-05
- Decision code
- OK30
- Date received
- 2020-07-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process changes related to the AFX2 implant loading procedure into the delivery system.