PMA P120006S010
- Device
- OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S010
- Product code
- MIH
- Decision date
- 2014-09-30
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR CHANGES TO THE CUSTOMSEAL KIT TO ACHIEVE A SHORTER CURE TIME OF THE FILL POLYMER.
Current openFDA PMA Record#
- Device
- OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S010
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-09-30
- Decision code
- APPR
- Date received
- 2014-01-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE CUSTOMSEAL KIT TO ACHIEVE A SHORTER CURE TIME OF THE FILL POLYMER.