ApprovalTrail

Medical device licence · 83779 · Class 4

RESTORESENSOR MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR

Yes: licensed in Canada

Licence status Issued (active); first licensed August 27, 2010. It is in Health Canada’s list of active licences.
Licence number
83779
Licence holder
Medtronic Inc.Minneapolis, MN, United States
Risk class
Class IV (highest risk)
Licence type
System
First licensed
August 27, 2010
Devices covered
7

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • COMMUNICATION MANAGER APPLICATION
  • PATIENT DATA SERVICE APPLICATION
  • RESTORE CLINICIAN PROGRAMMER APPLICATION
  • RESTORESENSOR MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR
  • RESTORESENSOR MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR-CHARGING SYSTEM
  • RESTORESENSOR MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR-N'VISION APPL CARD
  • RESTORESENSOR MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR-PATIENT 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 “restoresensor”. A notice may cover another product or only some lots: read it to see what it covers.

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.