Patient monitor, pressure, intracranial

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

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Public Summary

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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.

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