Medical device licence · 98206 · Class 3
OSTEOCOOL RF ABLATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 9, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98206
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 9, 2016
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OSTEOCOOL CONNECTOR HUB
- OSTEOCOOL INDEPENDENT THERMOCOUPLE KIT
- OSTEOCOOL PUMP UNIT & OSTEOCOOL PUMP CABLE
- OSTEOCOOL RADIOFREQUENCY GENERATOR
- OSTEOCOOL RF ABLATION PROBE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.