Medical device licence · 90072 · Class 3
VISUAL-ICE CRYOABLATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 9, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 90072
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 9, 2012
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ICEROD 1.5 CX STRAIGHT NEEDLE
- ICESEED 1.5 CX 90 NEEDLE
- ICESEED 1.5 CX S 90 NEEDLE
- ICESEED 1.5 CX STRAIGHT NEEDLE
- ICESPHERE 1.5 CX STRAIGHT NEEDLE
- SOFTWARE REVISION 1.2.2
- SOFTWARE REVISION 1.3.1
- SOFTWARE REVISION 1.4.1
- VISUAL-ICE CRYOABLATION SYSTEM - ARGON SUPPLY LINE
- VISUAL-ICE CRYOABLATION SYSTEM - CYLINDER ADAPTER
- VISUAL-ICE CRYOABLATION SYSTEM - HELIUM SUPPLY LINE
- VISUAL-ICE CRYOABLATION SYSTEM - MAIN UNIT
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “visual-ice”. A notice may cover another product or only some lots: read it to see what it covers.
- Visual-ICE Cryoablation System (2019-10-25)November 8, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.