Medical device licence · 111047 · Class 4
FARAPULSE PULSED FIELD ABLATION SYSTEM
Yes: licensed in Canada
Licence status Issued with conditions; first licensed April 4, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111047
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- April 4, 2024
- Devices covered
- 29
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FARADRIVE STEERABLE SHEATH
- FARAPOINT BIDIRECTIONAL / D-F CURVE PULSED FIELD ABLATION CATHETER
- FARAPOINT BIDIRECTIONAL / F-F CURVE PULSED FIELD ABLATION CATHETER
- FARASTAR CATHETER CONNECTION CABLE
- FARASTAR EGM CABLE
- FARASTAR EGM TO EP RECORDING SYSTEM CABLE (FARAPOINT)
- FARASTAR INTER-CONNECTION BOX
- FARASTAR MAPPING SYSTEM MODULE
- FARASTAR MAPPING SYSTEM MODULE ABL OUTPUT TO SIGNAL STATION ABL INPUT CABLE, FARASTAR TO OPAL HDX
- FARASTAR MAPPING SYSTEM MODULE AUXILIARY CABLE
- FARASTAR MAPPING SYSTEM MODULE BACK PATCH CABLE
- FARASTAR MAPPING SYSTEM MODULE BACK PATCH CABLE MALE
- FARASTAR MAPPING SYSTEM MODULE BNC-PHONO CABLE
- FARASTAR PULSED FIELD ABLATION GENERATOR
- FARASTAR PULSED FIELD ABLATION GENERATOR AND COMPONENTS
- FARASTAR RECORDING SYSTEM MODULE
- FARASTAR RECORDING SYSTEM MODULE AND COMPONENTS
- FARASTAR RECORDING SYSTEM MODULE CATHETER PIN CABLE
- FARASTAR RECORDING SYSTEM MODULE ECG OUTPUT MODULE
- FARASTAR RECORDING SYSTEM MODULE ECG OUTPUT TO SIGNAL STATION ECG INPUT CABLE, FARASTAR TO OPAL HDX
- FARASTAR RECORDING SYSTEM MODULE ECG TRUNK CABLE
- FARASTAR RECORDING SYSTEM MODULE EGM INPUT MODULE
- FARASTAR RECORDING SYSTEM MODULE EGM OUTPUT TO SINGAL STATION EGM INPUT CABLE, FARASTAR TO OPAL HDX
- FARASTAR STIMULATION MODULE CABLE
- FARASTAR STIMULATION MODULE FEMALE CABLE
- FARASTAR STIMULATION MODULE MALE CABLE
- FARASTAR STIMULATION MODULE Y-CABLE
- FARAWAVE NAV PULSED FIELD ABLATION CATHETER
- FARAWAVE PULSED FIELD ABLATION CATHETER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.