Medical device licence · 104008 · Class 4
SPECTRA WAVEWRITER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 10, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 104008
- Licence holder
- Boston Scientific Neuromodulation CorporationValencia, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- December 10, 2019
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIONIC NAVIGATOR 3D 2.10 INSTALLER
- BIONIC NAVIGATOR 3D 2.20 INSTALLER
- BIONIC NAVIGATOR 3D 4.1 SOFTWARE
- CLINICIAN PROGRAMMER
- CLINICIAN PROGRAMMER (REFURBISHED)
- FREELINK REMOTE CONTROL
- FREELINK REMOTE CONTROL KIT
- INFINION PRO LEAD KIT
- PATIENT TRIAL KIT
- SPECTRA WAVEWRITER EXTERNAL TRIAL STIMULATOR
- SPECTRA WAVEWRITER IMPLANTABLE PULSE GENERATOR AND CHARGING KIT
- SPECTRA WAVEWRITER IMPLANTABLE PULSE GENERATOR KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.