Mesh

Main information

  • Trade name:
  • Mesh, polymeric, non-biodegradable
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Mesh, polymeric, non-biodegradable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218667
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218667

Getinge Australia Pty Ltd - Mesh, polymeric, non-biodegradable

ARTG entry for

Medical Device Included Class IIb

Sponsor

Getinge Australia Pty Ltd

Postal Address

PO Box 50,BULIMBA, QLD, 4171

Australia

ARTG Start Date

19/12/2013

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

Proxy Biomedical Ltd

Coilleach Spiddal Co

, Galway,

Ireland

Products

1. Mesh, polymeric, non-biodegradable

Product Type

Single Device Product

Effective date

19/12/2013

GMDN

44689 Mesh, polymeric, non-biodegradable

Intended purpose

Polypropylene Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other

fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

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 09:45:32 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

17-1-2018

TGA actions after review into urogynaecological surgical mesh implants

TGA actions after review into urogynaecological surgical mesh implants

Update - Stress Urinary Incontinence (SUI) mid-urethral slings

Therapeutic Goods Administration - Australia

There are no news related to this product.