PMA P040002S063
- Device
- AFX Endovascular AAA System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S063
- Product code
- MIH
- Decision date
- 2019-08-16
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Modifications to the routine endotoxin (pyrogen) testing sampling plan for the AFX Endovascular AAA System.
Current openFDA PMA Record#
- Device
- AFX Endovascular AAA System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S063
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2019-08-16
- Decision code
- OK30
- Date received
- 2019-07-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the routine endotoxin (pyrogen) testing sampling plan for the AFX Endovascular AAA System.