PMA P040002
- Device
- AFX2 Endovascular AAA System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S070
- Product code
- MIH
- Decision date
- 2024-09-27
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- implementation of a revised ethylene oxide sterilization cycle at one of the sterilization sites and use of a new biological indicator
Current openFDA PMA Record#
- Device
- AFX2 Endovascular AAA System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S075
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2024-09-27
- Decision code
- OK30
- Date received
- 2024-08-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a revised ethylene oxide sterilization cycle at one of the sterilization sites and use of a new biological indicator