LICOX

Main information

  • Trade name:
  • LICOX Complete Brain Tunneling Probe Kit, IT2 - Surgical procedure kit, neurosurgical, single-use, non-medicated
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • LICOX Complete Brain Tunneling Probe Kit, IT2 - Surgical procedure kit, neurosurgical, single-use, non-medicated
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218940
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218940

Integra Neurosciences Pty Ltd - LICOX Complete Brain Tunneling Probe Kit, IT2 - Surgical procedure kit,

neurosurgical, single-use, non-medicated

ARTG entry for

Medical Device Included Class III

Sponsor

Integra Neurosciences Pty Ltd

Postal Address

Unit 3 / 24-30 Winterton Road,CLAYTON, VIC, 3168

Australia

ARTG Start Date

6/01/2014

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Integra NeuroSciences Implants SAS

2905 Route Des Dolines

Sophia Antipolis, Cedex, 06921

France

Products

1. LICOX Complete Brain Tunneling Probe Kit, IT2 - Surgical procedure kit, neurosurgical, single-use,

non-medicated

Product Type

Medical device system

Effective date

6/01/2014

GMDN

44063 Surgical procedure kit, neurosurgical, single-use, non-medicated

Functional description

The kit consists of a parenteral probe guide with integral trocar Ref VK5.2 and combined oxygen and

temperature probe Ref CC1.P1. The parenteral probe guide, a small diameter plastic tube with attached

trocar, is designed to be "tunneled" under the scalp and provides fixation for the CC1.P1 probe. The probe

may be implanted after craniotomy through a burr or drill hole at the margin of an existing bone flap. The

system is designed for no more than five days of continuous monitoring.

Intended purpose

The Licox Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is

intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral

tissue local to sensor placement. Licox System values are relative within an individual, and should not be

used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to

that obtained by current clinical practice in cases where hypoxia or ischemia are a concern

Variant information

Nil variant (as 1 device)

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 08:59:11 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information