Medical device licence · 95944 · Class 4
PRECISION NOVI SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 20, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95944
- Licence holder
- Boston Scientific Neuromodulation CorporationValencia, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 20, 2015
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIONIC NAVIGATOR 1.2 INSTALLER
- BIONIC NAVIGATOR 3D 2.20 INSTALLER
- BIONIC NAVIGATOR 3D 4.1 SOFTWARE
- BIONIC NAVIGATOR INSTALLER
- CLIK X ANCHOR
- CLINICIAN PROGRAMMER
- CLINICIAN PROGRAMMER (REFURBISHED)
- ENTRADA NEEDLE
- ENTRADA SPARE SHEATH
- FREELINK REMOTE CONTROL
- FREELINK REMOTE CONTROL KIT
- INSTALLER FOR BN3.1
- PATIENT TRIAL KIT
- PRECISION NOVI IMPLANTABLE PULSE GENERATOR AND FREELINK RC KIT
- PRECISION NOVI IMPLANTABLE PULSE GENERATOR KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.