Medical device licence · 99611 · Class 4
INTERSTIM II SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 8, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99611
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- September 8, 2017
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLINICIAN APP FOR SACRAL NEUROMODULATION THERAPY
- HANDSET WITH COMMUNICATOR
- INTERSTIM II NEUROSTIMULATOR SYSTEM - IMPLANTABLE STIMULATOR
- INTERSTIM PERCUTANEOUS EXTENSION
- INTERSTIM QUADRIPOLAR LEAD
- INTERSTIM REVISION KIT
- INTERSTIM SURESCAN MRI LEAD KIT
- INTERSTIM SYSTEM - ICON PATIENT PROGRAMMER
- INTRODUCER KIT
- N'VISION APPLICATION CARD
- PATIENT THERAPY APP FOR SACRAL NEUROMODULATION THERAPY
- RESTOREADVANCED MULTI-PROGRAM NEUROSTIMULATOR-N'VISION CLINICIAN PROGRAMMER
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 “interstim”. A notice may cover another product or only some lots: read it to see what it covers.
- InterStim™ SystemsSeptember 24, 2026 · Gastroenterology and urology · Device compatibility · Type II
- Interstim Percutaneous ExtensionJanuary 24, 2022 · Gastroenterology and urology · Increased risk or new adverse events · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.