Medical device licence · 89741 · Class 4
ITREL 4 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 25, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89741
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- September 25, 2012
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMMUNICATION MANAGER APPLICATION
- ITREL 4 SYSTEM - IMPLANTABLE NEUROSTIMULATOR (INS)
- ITREL 4 SYSTEM - N'VISION APPLICATION CARD
- PATIENT DATA SERVICE APPLICATION
- RESTORE CLINICIAN PROGRAMMER APPLICATION
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 “itrel”. A notice may cover another product or only some lots: read it to see what it covers.
- Itrel 3 System and Enterra Therapy Implantable Pulse Generator (IPG), and InterStim system - InterStim Implantable Stimulator (2015-01-08)January 21, 2015 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.