Scalp cooling system

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

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Available from:
Med-Ideology Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322762

Public Summary

Summary for ARTG Entry:

322762

Med-Ideology Pty Ltd - Scalp cooling system

ARTG entry for

Medical Device Included Class IIa

Sponsor

Med-Ideology Pty Ltd

Postal Address

PO Box 510,Baulkham Hills, NSW, 2153

Australia

ARTG Start Date

6/09/2019

Product category

Medical Device Class IIa

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

Dignitana AB

Traktorgranden 3

Lund, Sweden, 226 60

Sweden

Products

1. Scalp cooling system

Product Type

Single Device Product

Effective date

6/09/2019

GMDN

62231 Scalp cooling system

Intended purpose

Scalp cooling is intended to constrict blood vessels in the scalp, which reduces the amount of

chemotherapy that reaches cells in the hair follicles. The cold temperature also decreases the activity of

the hair follicles and slows down cell division, making them less affected by chemotherapy. The combined

actions reduce the effect chemotherapy has on the cells, which may prevent / minimise hair loss.

Specific Conditions

© 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 02.11.2019 at 05:02:05 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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