Medical device licence · 90249 · Class 4
PRECISION SPECTRA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 4, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 90249
- Licence holder
- Boston Scientific Neuromodulation CorporationValencia, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- December 4, 2012
- Devices covered
- 25
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
- CLIK X ANCHOR
- CLINICIAN PROGRAMMER
- CLINICIAN PROGRAMMER (REFURBISHED)
- COVEREDGE PADDLE BLANK
- COVEREDGE SURGICAL LEAD KIT
- ENTRADA NEEDLE
- ENTRADA SPARE SHEATH
- INFINION CX CONTACT LEAD KIT
- PRECISION M8 ADAPTER
- PRECISION S8 ADAPTER
- PRECISION S8 TRIAL ADAPTER
- PRECISION SPECTRA OMG ADAPTER
- PRECISION SPECTRA SYSTEM - CLINICIAN PROGRAMMER
- PRECISION SPECTRA SYSTEM - COVEREDGE SURGICAL LEAD KIT
- PRECISION SPECTRA SYSTEM - EXTERNAL TRIAL STIMULATOR
- PRECISION SPECTRA SYSTEM - IMPLANTABLE PULSE GENERATOR
- PRECISION SPECTRA SYSTEM - IPG PORT PLUG
- PRECISION SPECTRA SYSTEM - OR CABLE
- PRECISION SPECTRA SYSTEM - PADDLE BLANK FOR COVEREDGE SURGICAL LEAD
- PRECISION SPECTRA SYSTEM - PROGRAMMING WAND
- PRECISION SPECTRA SYSTEM - REMOTE CONTROL
- PRECISION SPECTRA SYSTEM - REMOTE CONTROL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.