Integra

Main information

  • Trade name:
  • Integra Licox PtO2 and Temperature Monitor - Patient monitor, multiparameter
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Integra Licox PtO2 and Temperature Monitor - Patient monitor, multiparameter
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217355
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217355

Integra Neurosciences Pty Ltd - Integra Licox PtO2 and Temperature Monitor - Patient monitor,

multiparameter

ARTG entry for

Medical Device Included Class IIb

Sponsor

Integra Neurosciences Pty Ltd

Postal Address

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

Australia

ARTG Start Date

15/11/2013

Product category

Medical Device Class IIb

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 LifeSciences (Ireland) Ltd

IDA Business and Technology Park Sragh

Tullamore, County Offaly,

Ireland

Products

1. Integra Licox PtO2 and Temperature Monitor - Patient monitor, multiparameter

Product Type

Medical device system

Effective date

15/11/2013

GMDN

33586 Single-patient physiologic monitoring system

Intended purpose

The Integra Licox PtO2 and Temperature Monitor measures oxygen partial pressure (PtO2) and

temperature in brain tissue and these paramters are used as an aid in determination of the perfusion

status of brain tissue.

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 02:33:34 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

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