Medical device licence · 108202 · Class 3
ENSITE X EP SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 24, 2022; ended November 21, 2023. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 108202
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 24, 2022
- Ended
- November 21, 2023
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENSITE X EP SYSTEM DISPLAY WORKSTATION
- ENSITE X EP SYSTEM SOFTWARE UPGRADE
- ENSITE X EP SYSTEM, TACTIFLEX ABLATION CATHETER, SENSOR ENABLED, SOFTWARE UPGRADE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.