PMA P040002S056
- Device
- AFX ENDOVASCULAR AAA STENT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S056
- Product code
- MIH
- Decision date
- 2015-11-18
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- AN ALTERNATE SUPPLIER TO PERFORM MICROBIOLOGICAL TESTING.
Current openFDA PMA Record#
- Device
- AFX ENDOVASCULAR AAA STENT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S056
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2015-11-18
- Decision code
- OK30
- Date received
- 2015-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AN ALTERNATE SUPPLIER TO PERFORM MICROBIOLOGICAL TESTING.