Post

Main information

  • Trade name:
  • Post Craniotomy Subdural Pressure Monitoring Kit, 110-4G - Catheter, neurological, ventricular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Post Craniotomy Subdural Pressure Monitoring Kit, 110-4G - Catheter, neurological, ventricular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218134
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218134

Integra Neurosciences Pty Ltd - Post Craniotomy Subdural Pressure Monitoring Kit, 110-4G - Catheter,

neurological, ventricular

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

5/12/2013

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

5955 Pacific Center Boulevard

San Diego, CA, 92121

United States Of America

Products

1. Post Craniotomy Subdural Pressure Monitoring Kit, 110-4G - Catheter, neurological, ventricular

Product Type

Medical device system

Effective date

5/12/2013

GMDN

32585 Catheter, neurological, ventricular

Functional description

Kit consists of a catheter with a transducer at the distal end that monitors intracranial pressure when

attached to a monitor. Kit includes a trocar with a guide tube to aid in insertion of the catheter.

Intended purpose

The Camino Post Craniotomy Subdural Pressure Monitoring Kit is intended to measure intracranial

pressure in the subdural space, post craniotomy.

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 11:43:32 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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