Medical device licence · 96434 · Class 3
NEUROSTIMULATION TRIAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 26, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96434
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 26, 2016
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CR2450 BATTERY
- EXTERNAL PULSE GENERATOR, 16 CHANNEL
- EXTERNAL PULSE GENERATOR, 2 PORT HEADER
- SCS EPG, 2 PORT HEADER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.