ApprovalTrail

Medical device licence · 106329 · Class 4

VERCISE GENUS DEEP BRAIN STIMULATION SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed June 29, 2021. It is in Health Canada’s list of active licences.
Licence number
106329
Licence holder
Boston Scientific Neuromodulation CorporationValencia, CA, United States
Risk class
Class IV (highest risk)
Licence type
System
First licensed
June 29, 2021
Devices covered
16

Devices on this licence

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

  • 16 CONTACT, PUSH BUTTON OR CABLE
  • 8 CONTACT, PUSH BUTTON OR CABLE
  • CLINICIAN PROGRAMMER (REFURBISHED)
  • LEAD EXTENSION KIT
  • PAIRING MAGNET
  • PHYSICIAN'S SPARE KIT
  • TUNNELING TOOL
  • VERCISE CARTESIA X DIRECTIONAL LEAD KIT
  • VERCISE CLINICIAN PROGRAMMER
  • VERCISE DBS REMOTE CONTROL 4
  • VERCISE DBS REMOTE CONTROL 4 KIT
  • VERCISE ETS 3
  • VERCISE GENUS P16 IMPLANTABLE PULSE GENERATOR KIT
  • VERCISE NEURAL NAVIGATOR 4 INSTALLER
  • VERCISE NEURAL NAVIGATOR 5 SOFTWARE
  • 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.