PMA P040002S052
- Device
- AFX ENDOVASULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S052
- Product code
- MIH
- Decision date
- 2014-07-09
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- ALTERNATE METHOD FOR THE HEAT-SHRINK PROCESS.
Current openFDA PMA Record#
- Device
- AFX ENDOVASULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S052
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-07-09
- Decision code
- OK30
- Date received
- 2014-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE METHOD FOR THE HEAT-SHRINK PROCESS.