ApprovalTrail

Medical device licence · 65231 · Class 4

C-SERIES PULSE GENERATORS

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed July 20, 2004; ended August 18, 2010. It is in Health Canada’s archive of licences no longer in force.
Licence number
65231
Licence holder
Vitatron Holding B.V.Maastricht, Netherlands
Risk class
Class IV (highest risk)
Licence type
Device Family
First licensed
July 20, 2004
Ended
August 18, 2010
Devices covered
4

Devices on this licence

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

  • C10S SINGLE CHAMBER PACEMAKER (SSI)
  • C20SR SINGLE CHAMBER RATE RESPONSIVE PACEMAKER (SSIR)
  • C50D DUAL CHAMBER PACEMAKER (DDD)
  • C60DR DUAL CHAMBER RATE RESPONSIVE PACEMAKER (DDDR)

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 “c-series”. 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.