Medical device licence · 83463 · Class 3
GENIUS MULTI-CHANNEL RF ABLATION GENERATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed August 3, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83463
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 3, 2010
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GENIUS CARDIAC ABLATION SYSTEM - CATHETER INTERFACE CABLE
- GENIUS CARDIAC ABLATION SYSTEM - ECG (12 LEAD) AMPLIFIER CABLE
- GENIUS CARDIAC ABLATION SYSTEM - ECG INTERFACE BOX
- GENIUS CARDIAC ABLATION SYSTEM - ECG INTERFACE BOX CABLE
- GENIUS CARDIAC ABLATION SYSTEM - MULTI-CHANNEL RF ABLATION GENERATOR
- GENIUS CARDIAC ABLATION SYSTEM - MULTI-CHANNEL RF GENERATOR REMOTE CONTROL
- GENIUS CARDIAC ABLATION SYSTEM - REMOTE CONTROL CABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.