ApprovalTrail

Medical device licence · 105677 · Class 4

WAVEWRITER ALPHA SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed January 5, 2021. It is in Health Canada’s list of active licences.
Licence number
105677
Licence holder
Boston Scientific Neuromodulation CorporationValencia, CA, United States
Risk class
Class IV (highest risk)
Licence type
System
First licensed
January 5, 2021
Devices covered
18

Devices on this licence

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

  • BIONIC NAVIGATOR 3D 4.0 INSTALLER
  • BIONIC NAVIGATOR 3D 4.1 SOFTWARE
  • CLINICIAN PROGRAMMER
  • CLINICIAN PROGRAMMER (REFURBISHED)
  • COVEREDGE MRI SURGICAL LEAD KIT
  • ETS TRIAL BELT
  • FREELINK REMOTE CONTROL
  • FREELINK REMOTE CONTROL KIT
  • INFINION PRO LEAD KIT
  • MYSCS GO THERAPY CONTROLLER
  • MYSCS GO THERAPY CONTROLLER APP
  • PAIRING MAGNET
  • PATIENT TRIAL KIT
  • PRECISION M8 ADAPTER
  • PRECISION S8 ADAPTER
  • WAVEWRITER ALPHA EXTERNAL TRIAL STIMULATOR
  • WAVEWRITER ALPHA IMPLANTABLE PULSE GENERATOR AND CHARGING KIT
  • WAVEWRITER ALPHA IMPLANTABLE PULSE GENERATOR KIT

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 “wavewriter”. 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.