PMA P120006S023
- Device
- OVATION ABDOMINAL STENT GRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S023
- Product code
- MIH
- Decision date
- 2016-05-05
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for a change in bottom material for the inner and outer pouch for the AutoInjector.
Current openFDA PMA Record#
- Device
- OVATION ABDOMINAL STENT GRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S023
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2016-05-05
- Decision code
- APPR
- Date received
- 2016-02-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in bottom material for the inner and outer pouch for the AutoInjector.