Medical device licence · 80689 · Class 3
ENSITE VELOCITY
Yes: licensed in Canada
Licence status Issued (active); first licensed September 17, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80689
- Licence holder
- St. Jude MedicalMaple Grove, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 17, 2009
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AUTOMARK MODULE
- ENSITE AUTOMAP MODULE V1.0
- ENSITE CONTACT FORCE MODULE
- ENSITE COURIER
- ENSITE DEREXI MODULE V1.3.1
- ENSITE FUSION REGISTRATION MODULE V7.1
- ENSITE VELOCITY - MAIN UNIT
- ENSITE VELOCITY - SOFTWARE
- ENSITE VELOCITY CARDIAC MAPPING SYSTEM SOFTWARE UPGRADE KIT V5.0
- ENSITE VELOCITY SOFTWARE INSTALLATION
- ENSITE VERISMO SEGMENTATION TOOL SOFTWARE
- FTI THRESHOLD KIT
- FTI-LSI KIT
- LSI THRESHOLD KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.