Medical device licence · 105968 · Class 4
WAVEWRITER ALPHA SYSTEM - ALPHA PRIME
Yes: licensed in Canada
Licence status Issued (active); first licensed March 25, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105968
- Licence holder
- Boston Scientific Neuromodulation CorporationValencia, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- March 25, 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 PRIME IMPLANTABLE PULSE GENERATOR AND REMOTE CONTROL KIT
- WAVEWRITER ALPHA PRIME 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.
- Wavewriter Alpha Implantable Pulse Generator KitAugust 14, 2024 · Cardiovascular · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.