Medical device licence · 115141 · Class 3
CURRENT PFA
Yes: licensed in Canada
Licence status Issued (active); first licensed April 1, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115141
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 1, 2026
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CURRENT PFA ECG TRUNK CABLE
- CURRENT PFA GENERATOR
- CURRENT PFA GENERATOR CART
- CURRENT PFA GENERATOR SOFTWARE UPGRADE
- CURRENT PFA RADIOLUCENT ECG LEAD SET
- CURRENT PFA RADIOPAQUE ECG LEAD SET
- CURRENT PFA RECORDING SYSTEM CONNECT CABLE
- CURRENT PFA UNIFIED CABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.