ApprovalTrail

Medical device licence · 11652 · Class 4

COLLECTION

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed September 20, 1999; ended August 18, 2010. It is in Health Canada’s archive of licences no longer in force.
Licence number
11652
Licence holder
Vitatron Holding B.V.Maastricht, Netherlands
Risk class
Class IV (highest risk)
Licence type
System
First licensed
September 20, 1999
Ended
August 18, 2010
Devices covered
10

Devices on this licence

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

  • DIAMOND 3 DDDR
  • DIAMOND II MULTISENSOR DDDR PACEMAKER WITH/OUT PARYLENE IS-1 BIPOLAR
  • JADE 3 SSI/R
  • JADE II SINGLE CHAMBER PACEMAKER SSI
  • RUBY 3 DDD
  • RUBY II DUAL CHAMBER PACEMAKER WITH/OUT PARYLENE IS-1 BIPOLAR
  • SAPHIR 3 VDDR
  • SAPHIR II MULTISENSOR SINGLE LEAD VDD/R PACEMAKER IS-1 BIPOLAR
  • TOPAZ 3 SSIR
  • TOPAZ II AUTOMATIC DUAL SENSOR PACEMAKER WITH/OUT PARYLENE IS-1 BL

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