PMA P120006S016
- Device
- TRI VASCULAR, INC. OVATION /OVATION ABDOMINAL STENT GRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S016
- Product code
- MIH
- Decision date
- 2014-11-20
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- MODIFIED AND NEW TOOLS FOR USE IN THE PROCESS FOR LOADING THE STENT GRAFTS INTOTHE DELIVERY SYSTEM SHEATHS.
Current openFDA PMA Record#
- Device
- TRI VASCULAR, INC. OVATION /OVATION ABDOMINAL STENT GRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S016
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-11-20
- Decision code
- OK30
- Date received
- 2014-10-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFIED AND NEW TOOLS FOR USE IN THE PROCESS FOR LOADING THE STENT GRAFTS INTOTHE DELIVERY SYSTEM SHEATHS.