PMA P120006S017
- Device
- TRIVASCULAR, INC OVATION/OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S017
- Product code
- MIH
- Decision date
- 2015-01-14
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE CUSTOMSEAL KIT.
Current openFDA PMA Record#
- Device
- TRIVASCULAR, INC OVATION/OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S017
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2015-01-14
- Decision code
- APPR
- Date received
- 2014-10-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE CUSTOMSEAL KIT.