ApprovalTrail

Medical device licence · 87657 · Class 3

SOPHONO BONE CONDUCTION HEARING SYSTEM

No longer licensed: cancelled

Licence status Cancelled; first licensed November 16, 2011; ended May 8, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
87657
Licence holder
Medtronic Xomed Inc.Jacksonville, FL, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
November 16, 2011
Ended
May 8, 2025
Devices covered
3

Devices on this licence

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

  • OTOMAG ALPHA (M) MAGNETIC IMPLANT, STERILE
  • OTOMAG ALPHA 1(M) BONE CONDUCTION HEARING SYSTEM (IMPLANT)
  • SOPHONO MAGNETIC IMPLANT

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