PMA P040002S031
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S031
- Product code
- MIH
- Decision date
- 2011-05-06
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR A NEW EPTFE GRAFT PROCESS AS WELL AS CHANGES TO THE DELIVERY SYSTEM.
Current openFDA PMA Record#
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S031
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2011-05-06
- Decision code
- APPR
- Date received
- 2010-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A NEW EPTFE GRAFT PROCESS AS WELL AS CHANGES TO THE DELIVERY SYSTEM.