Medical device licence · 110642 · Class 4
AURORA EV-ICD SYSTEM
Yes: licensed in Canada
Licence status Issued with conditions; first licensed January 2, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 110642
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- January 2, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AURORA EV-ICD MRI SURESCAN
- EPSILA EV MRI SURESCAN LEAD
- EPSILA EV STERNAL TUNNELING TOOL
- EPSILA EV TRANSVERSE TUNNELING TOOL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.