ApprovalTrail

Medical device licence · 87485 · Class 3

PLASMAJET SYSTEM

No longer licensed: suspended: invalid quality-system certificate

Licence status Suspended: invalid quality-system certificate; first licensed October 24, 2011; ended July 29, 2019. It is in Health Canada’s archive of licences no longer in force.
Licence number
87485
Licence holder
Plasma Surgical IncorporatedAbingdon, OX, United Kingdom
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
October 24, 2011
Ended
July 29, 2019
Devices covered
10

Devices on this licence

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

  • PLASMAJET SYS - SINGLE USE CUT/COAGU. FOR LAPAROSCOPIC SURGERY HAND-SWITCHED
  • PLASMAJET SYS - SINGLE USE CUT/COAGU. FOR LAPAROSCOPIC SURGERY UN-SWITCHED
  • PLASMAJET SYSTEM - CONSOLE
  • PLASMAJET SYSTEM - FOOTSWITCH
  • PLASMAJET SYSTEM - POWER CORD
  • PLASMAJET SYSTEM - SERVICE MODULE
  • PLASMAJET SYSTEM - SINGLE USE COAGU. FOR LAPAROSCOPIC SURGERY HAND-SWITCHED
  • PLASMAJET SYSTEM - SINGLE USE COAGU. FOR LAPAROSCOPIC SURGERY UN-SWITCHED
  • PLASMAJET SYSTEM - SINGLE USE COAGULATION HANDPIECE FOR OPEN SURGERY
  • PLASMAJET SYSTEM - SINGLE USE CUT COAGULATION HANDPIECE FOR OPEN SURGERY

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.