Medical device licence · 97814 · Class 3
ENSITE PRECISION CARDIAC MAPPING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 13, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97814
- Licence holder
- St. Jude MedicalMaple Grove, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 13, 2016
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARRAYLINK MODULE
- CATHLINK MODULE
- ENSITE MEDIGUIDE INTERFACE MODULE
- ENSITE PRECISION BEDRAIL MOUNT KIT
- ENSITE PRECISION FIELD FRAME
- ENSITE PRECISION FIELD FRAME BRACKET
- ENSITE PRECISION FIELD FRAME CABLE
- ENSITE PRECISION LINK, SENSOR ENABLED
- ENSITE PRECISION MODULE, SENSOR ENABLED
- ENSITE PRECISION PATIENT REFERENCE SENSOR
- ENSITE PRECISION POWER SUPPLY KIT
- ENSITE PRECISION SOFTWARE INSTALLATION
- ENSITE PRECISION SOFTWARE UPGRADE
- ENSITE PRECISION V.2.0.0
- ENSITE VELOCITY - MAIN UNIT
- ENSITE VELOCITY CARDIAC MAPPING SYSTEM SOFTWARE UPGRADE KIT V5.0
- ENSITE VELOCITY SYSTEM DISPLAY WORKSTATION KIT
- NAVLINK MODULE
- RECORDCONNECT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.