ApprovalTrail

Medical device licence · 93641 · Class 4

VERCISE DEEP BRAIN STIMULATION (DBS) SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed July 28, 2014. It is in Health Canada’s list of active licences.
Licence number
93641
Licence holder
Boston Scientific Neuromodulation CorporationValencia, CA, United States
Risk class
Class IV (highest risk)
Licence type
System
First licensed
July 28, 2014
Devices covered
20

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
  • CABLE
  • CHARGER BELT
  • CLINICIAN PROGRAMMER (REFURBISHED)
  • CONTACT EXTENSION KIT
  • GUIDE DBS STATION
  • GUIDE XT INSTALLER
  • IR INTERFACE HOLDER
  • LEAD KIT
  • TUNNELING TOOL
  • VERCISE CHARGING COLLAR
  • VERCISE CHARGING SYSTEM
  • VERCISE CLINICIAN PROGRAMMER
  • VERCISE EXTERNAL TRIAL STIMULATOR
  • VERCISE IMPLANTABLE PULSE GENERATOR KIT
  • VERCISE M8 ADAPTER
  • VERCISE PHYSICIAN SPARES KIT
  • VERCISE REMOTE CONTROL

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.