LICOX

Main information

  • Trade name:
  • LICOX Double Lumen Introducer Kit, IP2 - Surgical procedure kit, neurosurgical, single-use, non-medicated
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • LICOX Double Lumen Introducer Kit, IP2 - Surgical procedure kit, neurosurgical, single-use, non-medicated
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218943
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218943

Integra Neurosciences Pty Ltd - LICOX Double Lumen Introducer Kit, IP2 - 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 Double Lumen Introducer Kit, IP2 - Surgical procedure kit, neurosurgical, single-use, non-medicated

Product Type

Procedure Pack

Effective date

6/01/2014

GMDN

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

Functional description

A bolt in secured through the skull for the introducer which is inserted into the dura for introduction of a

separately supplied sensor probe that is part of the Licox monitoring system; and may also be used to

introduce an ICP probe through the second lumen of the bolt introducer.

Intended purpose

A dual lumen bolt introducer for access of the Licox Brain Oxygen Monitoring System that 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. May also be used to provide access for ICP monitoring.

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 08:58:24 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