PMA P040002S067
- Device
- AFX Endovascular AAA System (AFX System)
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S067
- Product code
- MIH
- Decision date
- 2021-04-08
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Supplier and manufacturing changes for the suture material used in the AFX Endovascular AAA System.
Current openFDA PMA Record#
- Device
- AFX Endovascular AAA System (AFX System)
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S067
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-04-08
- Decision code
- OK30
- Date received
- 2021-03-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier and manufacturing changes for the suture material used in the AFX Endovascular AAA System.