PMA P120006S011
- Device
- TRIVASCULAR,INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S011
- Product code
- MIH
- Decision date
- 2014-03-20
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- EXTENSION OF THE HOLD TIME OF STRETCHED FILM IN THE MANUFACTURE OF THERETAINING WRAP.
Current openFDA PMA Record#
- Device
- TRIVASCULAR,INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S011
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-03-20
- Decision code
- OK30
- Date received
- 2014-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXTENSION OF THE HOLD TIME OF STRETCHED FILM IN THE MANUFACTURE OF THERETAINING WRAP.