Medical device licence · 115505 · Class 4
AFFERA ABLATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 3, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115505
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- June 3, 2026
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CATHETER EXTENSION CABLE
- HEXAFLOW IRRIGATION PUMP
- HEXAGEN RF GENERATOR
- HEXAPULSE PF GENERATOR
- SPHERE-9 CATHETER
- TUBING SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.