LICOX

Main information

  • Trade name:
  • LICOX Combined Oxygen and Temperature Probe, CC1.P1 - Electrode, ion selective, oxygen
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • LICOX Combined Oxygen and Temperature Probe, CC1.P1 - Electrode, ion selective, oxygen
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218942
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218942

Integra Neurosciences Pty Ltd - LICOX Combined Oxygen and Temperature Probe, CC1.P1 - Electrode,

ion selective, oxygen

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 Combined Oxygen and Temperature Probe, CC1.P1 - Electrode, ion selective, oxygen

Product Type

Single Device Product

Effective date

6/01/2014

GMDN

30204 Electrode, ion selective, oxygen

Functional description

The combined oxygen and temperature probe may be used for monitoring of oxygen partial pressure as

well as temperature in the cerebral white matter. The probe may be implanted after craniotomy through a

burr or drill hole at the margin of an existing bone flap. The oxygen sensing starts 4 to 6 mm from the tip of

the probe. The temperature sensing part starts 13 to 15 mm from the end of the probe's oxygen sensing

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

Intended purpose

A flexible sensor probe that is part of 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 08:58:41 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