Sizer

Main information

  • Trade name:
  • Sizer, mammary prosthesis
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sizer, mammary prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218989
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218989

JT Medical Pty Ltd - Sizer, mammary prosthesis

ARTG entry for

Medical Device Included Class IIa

Sponsor

JT Medical Pty Ltd

Postal Address

PO Box 1330,NORTH SYDNEY, NSW, 2059

Australia

ARTG Start Date

8/01/2014

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

Polytech Health & Aesthetics GmbH

Altheimer Strasse 32

Dieburg, , 64807

Germany

Products

1. Sizer, mammary prosthesis

Product Type

Single Device Product

Effective date

8/01/2014

GMDN

34178 Sizer, mammary prosthesis

Intended purpose

A surgical instrument used during breast replacement surgery that provides a size measurement and

estimation of form so that the appropriate mammary prosthesis may be selected.

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 10.11.2017 at 08:49:12 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