ApprovalTrail

Medical device licence · 100127 · Class 4

VERCISE GEVIA DEEP BRAIN STIMULATION SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed December 7, 2017. It is in Health Canada’s list of active licences.
Licence number
100127
Licence holder
Boston Scientific Neuromodulation CorporationValencia, CA, United States
Risk class
Class IV (highest risk)
Licence type
System
First licensed
December 7, 2017
Devices covered
28

Devices on this licence

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

  • ADHESIVE KIT
  • BIONIC NAVIGATOR 2.03 INSTALLER
  • BURR HOLE COVER KIT
  • CHARGER BELT
  • CLINICIAN PROGRAMMER (REFURBISHED)
  • CONTACT EXTENSION KIT
  • GUIDE DBS STATION
  • GUIDE XT INSTALLER
  • LEAD KIT
  • OR CABLE AND EXTENSION
  • PROGRAMMING WAND
  • TUNNELING TOOL
  • VERCISE CARTESIA DBS DIRECTIONAL LEAD KIT
  • VERCISE CHARGING COLLAR
  • VERCISE CHARGING SYSTEM
  • VERCISE CLINICIAN PROGRAMMER
  • VERCISE DBS EXTERNAL TRIAL STIMULATOR 2
  • VERCISE DBS PROGRAMMING WAND
  • VERCISE DBS REMOTE CONTROL 3
  • VERCISE DBS REMOTE CONTROL 3 KIT
  • VERCISE ETS ADAPTER
  • VERCISE GEVIA 16 CONTACT IMPLANTABLE PULSE GENERATOR KIT
  • VERCISE M8 ADAPTER
  • VERCISE NEURAL NAVIGATOR 2 INSTALLER
  • VERCISE NEURAL NAVIGATOR 3.0 INSTALLER
  • VERCISE NEURAL NAVIGATOR 5 SOFTWARE
  • VERCISE PHYSICIAN SPARES KIT
  • VERCISE S8 ADAPTER

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 “vercise”. 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.