Belotero Lips Shape - Synthetic-fluid tissue reconstructive material, anaesthetic

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

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Available from:
Merz Australia Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
291728

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Public Summary

Summary for ARTG Entry:

291728

Merz Australia Pty Ltd - Belotero Lips Shape - Synthetic-fluid tissue reconstructive material, anaesthetic

ARTG entry for

Medical Device Included Class III

Sponsor

Merz Australia Pty Ltd

Postal Address

PO Box 209,Mascot,Sydney, NSW, 2020

Australia

ARTG Start Date

19/07/2017

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

Anteis SA

18 Chemin des Aulx

Plan-Les-Ouates, , CH-1228

Switzerland

Products

1. Belotero Lips Shape - Synthetic-fluid tissue reconstructive material, anaesthetic

Product Type

Procedure Pack

Effective date

19/07/2017

GMDN

47887 Synthetic-fluid tissue reconstructive material, anaesthetic

Functional description

A sterile, non-pyrogenic, viscoelastic, colourless, transparent cross-linked sodium hyaluronate gel of

non-animal origin in a physiological phosphate buffer. Contains 0.3% of lidocaine hydrochloride. Pack

contains 1 sterile 0.6mL syringe with gel and 2 sterile 27G 1/2" needles.

Intended purpose

Belotero® Lips Shape is an injectable resorbable implant indicated to correct facial atrophic scars and to

enhance soft tissue volume (e.g. lip volume, severe oral commissures). The presence of lidocaine aims to

reduce local pain associated with the injection of the gel and to improve patient comfort.

Variant information

Nil variant (as 1 device) Not Applicable

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 11:35:05 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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