ApprovalTrail

Medical device licence · 12620 · Class 3

VOICE PROSTHESIS

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed September 28, 1999; ended October 21, 2008. It is in Health Canada’s archive of licences no longer in force.
Licence number
12620
Licence holder
Smiths Medical Asd Inc.Vernon Hills, Illinois, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
September 28, 1999
Ended
October 21, 2008
Devices covered
3

Devices on this licence

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

  • BIVONA DUCKBILL VOICE PROSTHESIS
  • BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS WITHOUT AIRFLOW PORT
  • VOICE PROSTHESIS ULTRA LOW RESISTANCE WITH AIRFLOW PORT

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