PMA P040002S036
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S036
- Product code
- MIH
- Decision date
- 2012-02-15
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- CHANGE TO YOUR EPTFE GRAFT MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S036
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-02-15
- Decision code
- OK30
- Date received
- 2012-01-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO YOUR EPTFE GRAFT MANUFACTURING PROCESS.