Medical device licence · 710 · Class 4
ORBIS HEART VALVE
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 15, 1999; ended November 2, 2007. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 710
- Licence holder
- Carbomedics Inc. A Sorin Group CompanyAustin, TX, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- January 15, 1999
- Ended
- November 2, 2007
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARBOMEDICS ORBIS HEART VALVE AORTIC
- CARBOMEDICS ORBIS HEART VALVE MITRAL
- CARBOMEDICS ORBIS UNIVERSAL HEART VALVE (AORTIC/MITRAL)
- CARBOMEDICS ORBIS UNIVERSAL HEART VALVE AORTIC
- CARBOMEDICS ORBIS UNIVERSAL HEART VALVE MITRAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.