PMA P040002S046
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S046
- Product code
- MIH
- Decision date
- 2014-06-18
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR A MODIFIED EPTFE GRAFT MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S046
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-06-18
- Decision code
- APPR
- Date received
- 2014-01-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MODIFIED EPTFE GRAFT MANUFACTURING PROCESS.