ApprovalTrail

Medical device licence · 189 · Class 4

AFFINITY PULSE GENERATORS

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed September 28, 1998; ended November 1, 2006. It is in Health Canada’s archive of licences no longer in force.
Licence number
189
Licence holder
St. Jude Medical, Cardiac Rhythm Management DivisionSylmar, CA, United States
Risk class
Class IV (highest risk)
Licence type
Single Device
First licensed
September 28, 1998
Ended
November 1, 2006
Devices covered
5

Devices on this licence

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

  • AFFINITY DC PULSE GENERATORS
  • AFFINITY DR PULSE GENERATOR
  • AFFINITY SR PULSE GENERATOR
  • AFFINITY VDR PULSE GENERATOR
  • APS III SOFTWARE MODEL 3303

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