Medical device licence · 69475 · Class 4
AB5000 CIRCULATORY SUPPORT SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed October 11, 2005; ended November 12, 2018. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 69475
- Licence holder
- Abiomed Inc.Danvers, MA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 11, 2005
- Ended
- November 12, 2018
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AB5000 CIRCULATORY SUPPORT SYST - PORTABLE DRIVER - CONSOLE UNCRATED/CRATED
- AB5000 CIRCULATORY SUPPORT SYSTEM - ARTERIAL VENTRICLE
- AB5000 CIRCULATORY SUPPORT SYSTEM - CART - UNCRATED AND CRATED
- AB5000 CIRCULATORY SUPPORT SYSTEM - MAIN UNIT - UNCRATED AND CRATED
- AB5000 CIRCULATORY SUPPORT SYSTEM - MALLEABLE/SHORT APICAL CANNULA
- AB5000 CIRCULATORY SUPPORT SYSTEM - PORTABLE DRIVER BATTERY PACK
- AB5000 CIRCULATORY SUPPORT SYSTEM - SILICONE ARTERIAL CANNULA ASSEMBLY
- AB5000 CIRCULATORY SUPPORT SYSTEM - VENTRICULAR/ATRIAL CANNULA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.