Supply unit, cooling

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

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Available from:
Avanos Medical Australia Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
293197

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Public Summary

Summary for ARTG Entry:

293197

Halyard Australia Pty Ltd - Supply unit, cooling

ARTG entry for

Medical Device Included Class IIb

Sponsor

Halyard Australia Pty Ltd

Postal Address

PO Box 385,MILSONS POINT, NSW, 1565

Australia

ARTG Start Date

25/08/2017

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

Halyard Health Inc

5405 Windward Parkway

Alpharetta, GA, 30004

United States Of America

Products

1. Supply unit, cooling

Product Type

Medical device system

Effective date

25/08/2017

GMDN

37147 Supply unit, cooling

Intended purpose

The HALYARD* COOLIEF* Cooled Radiofrequency Peristaltic Pump unit is to be used in conjunction with

a COOLIEF* Cooled RF Generator and with COOLIEF* TRANSDISCAL Cooled Radiofrequency Kit for

coagulation and decompression of the disc material for symptomatic patients with contained herniated

discs. It is also to be used with COOLIEF* SINERGY* cooled radiofrequency Kit and other cooled RF

probes to create RF lesions in nervous tissue including the sacral region.

This device is also indicated for creating radiofrequency lesions of the genicular nerves for the

management of moderate to severe knee pain.

HALYARD* COOLIEF Cooled Radiofrequency Peristaltic Pump Unit is used for closed-loop circulation of

sterile water through the system during the RF lesioning procedures.

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 03.11.2017 at 05:26:08 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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