Medical device licence · 14740 · Class 4
ITREL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 24, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 14740
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- November 24, 1999
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ITREL 3 SYSTEM EZ PATIENT PROGRAMMER
- ITREL 3 SYSTEM IMPLANTABLE PULSE GENERATOR
- ITREL 3 SYSTEM MEMORYMOD SOFTWARE - MODEL 7457
- ITREL CONSOLE PROGRAMMER
- ITREL EXTERNAL ANTENNA
- ITREL II IPG
- ITREL II MEMORYMOD
- ITREL II/3 EXTENSIONS
- ITREL MEMORYMOD
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.