Medical device licence · 110758 · Class 4
OPTIMIZER SMART MINI SYSTEM
Yes: licensed in Canada
Licence status Issued with conditions; first licensed February 2, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 110758
- Licence holder
- Impulse Dynamics (Usa) Inc.Marlton, NJ, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- February 2, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPTIMIZER SMART MINI CCM IMPLANTABLE PULSE GENERATOR
- OPTIMIZER SMART MINI SYSTEM GUARDIO CHARGER SYSTEM
- OPTIMIZER SMART MINI SYSTEM INTELIO PORTABLE PROGRAMMER SYSTEM
- OPTIMIZER SMART MINI SYSTEM VESTA CHARGER SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.