ApprovalTrail

Medical device licence · 36425 · Class 4

CARELINK PROGRAMMER

Yes: licensed in Canada

Licence status Issued (active); first licensed February 22, 2002. It is in Health Canada’s list of active licences.
Licence number
36425
Licence holder
Medtronic Inc.Minneapolis, MN, United States
Risk class
Class IV (highest risk)
Licence type
System
First licensed
February 22, 2002
Devices covered
22

Devices on this licence

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

  • ADAPTA, VERSA, SENSIA PULSE GENERATORS PROGRAMMING SOFTWARE
  • APPLICATION SOFTWARE (FOR VIVA, BRAVA, EVERA)
  • ATTESTA MRI SURESCAN / SPHERA MRI SURESCAN
  • CARELINK 8190 ANALYZER SOFTWARE
  • CARELINK ANALYSER AND SURGICAL CABLE
  • CARELINK PROGRAMMER
  • CARELINK REPLACEMENT CABLES
  • CARELINK TELEMETRY HEAD
  • CONCERTO, VIRTUOSO SOFTWARE
  • RELIA SOFTWARE
  • RV LEAD INTEGRITY ALERT FEATURE
  • SOFTWARE FOR CRT-D MRI SURESCAN SYSTEM
  • SOFTWARE SW035
  • SW009 SOFTWARE
  • SW022 MRI SOFTWARE V1.1
  • SW026 SOFTWARE
  • SW030 SOFTWARE
  • SW033 SOFTWARE 8.3
  • SW036 SOFTWARE
  • SW040 SOFTWARE
  • SW041 SOFTWARE
  • SW044 SOFTWARE

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 “carelink”. 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.