Medical device licence · 108343 · Class 4
DIAMONDTEMP ABLATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 6, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108343
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 6, 2022
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIAMONDTEMP ABLATION CATHETER
- DIAMONDTEMP CATHETER-TO-RF GENERATOR CABLE
- DIAMONDTEMP EGM CABLE
- DIAMONDTEMP FASTR RF GENERATOR
- DIAMONDTEMP FOOT SWITCH
- DIAMONDTEMP GENCONNECT CABLE
- DIAMONDTEMP GENERATOR CONNECTION BOX E
- DIAMONDTEMP IRRIGATION PUMP
- DIAMONDTEMP IRRIGATION TUBING SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.