PMA P120006S025
- Device
- OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S025
- Product code
- MIH
- Decision date
- 2016-08-17
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Implementation of a revised welding program and modification to the weld flange orientation which is used in the manufacturing of the Ovation Abdominal Stent Graft System.
Current openFDA PMA Record#
- Device
- OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S025
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2016-08-17
- Decision code
- OK30
- Date received
- 2016-07-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a revised welding program and modification to the weld flange orientation which is used in the manufacturing of the Ovation Abdominal Stent Graft System.