Patient monitor, pressure, intracranial

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Integra Neurosciences Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
339466

Public Summary

Summary for ARTG Entry:

339466

Integra Neurosciences Pty Ltd - Patient monitor, pressure, intracranial

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

14/07/2020

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 Production Corporation

11 Cabot Blvd

Mansfield, MA, 02048

United States Of America

Products

1 . Patient monitor, pressure, intracranial

Product Type

Single Device Product

Effective Date

14/07/2020

GMDN

16763 Patient monitor, pressure, intracranial

Intended Purpose

ICP monitor intended for use as an interface between compatible strain-gauge type pressure transducers and standard

physiological pressure monitoring systems. Also intended for use as an independent pressure monitor for displaying the mean,

systolic and diastolic values of a physiological pressure waveform in the absence of an external patient monitor.

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 22.07.2020 at 09:28:32 AEST

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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