ApprovalTrail

Medical device licence · 101291 · Class 3

STEALTHSTATION S8 SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed June 22, 2018. It is in Health Canada’s list of active licences.
Licence number
101291
Licence holder
Medtronic Navigation, Inc.Lafayette, CO, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
June 22, 2018
Devices covered
14

Devices on this licence

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

  • CAMERA CART STEALTH S8
  • CAMERA CART STEALTH S8 PREMIUM
  • EM KIT S8 CRANIAL ACC
  • EM KIT S8 CRANIAL UPGRADE
  • EM KIT S8 ENT ACC
  • EM KIT S8 ENT SIDE EMITTER
  • EM KIT S8 ENT UPGRADE
  • EM KIT S8 FLAT EMITTER
  • MAIN CART STEALTH S8 BASIC
  • MAIN CART STEALTH S8 EM CRANIAL
  • MAIN CART STEALTH S8 EM ENT
  • MAIN CART STEALTH S8 PLUS
  • MAIN CART STEALTH S8 PREMIUM
  • STEALTHSTATION S8 APPLICATION

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 “stealthstation”. 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.