Medical device licence · 61089 · Class 4
BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed December 5, 2002; ended September 14, 2012. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 61089
- Licence holder
- Abiomed Inc.Danvers, MA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- December 5, 2002
- Ended
- September 14, 2012
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM - BLOOD PUMP & CANNULA SET
- BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM - CONSOLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.