4D Dome

Main information

  • Trade name:
  • 4D Dome Semi Resorbable Mesh with Onlay patch - Abdominal hernia surgical mesh, composite-polymer
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • 4D Dome Semi Resorbable Mesh with Onlay patch - Abdominal hernia surgical mesh, composite-polymer
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222740
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222740

Alliance Surgical Pty Ltd - 4D Dome Semi Resorbable Mesh with Onlay patch - Abdominal hernia surgical

mesh, composite-polymer

ARTG entry for

Medical Device Included Class III

Sponsor

Alliance Surgical Pty Ltd

Postal Address

PO Box 265,FLOREAT, WA, 6014

Australia

ARTG Start Date

23/04/2014

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

Cousin Biotech SAS

8 Rue De L'Abbe Bonpain

Wervicq-Sud, , F-59117

France

Products

1. 4D Dome Semi Resorbable Mesh with Onlay patch - Abdominal hernia surgical mesh, composite-polymer

Product Type

Single Device Product

Effective date

23/04/2014

GMDN

44756 Abdominal hernia surgical mesh, composite-polymer

Functional description

The dome mesh and onlay patch are packaged together as a plug and patch technique. The dome mesh

is a semiresorbable reinforcement parietal implant, constructed of 10% non-resorbable light polypropylene

and 90% resorbable PLLA in which the PLLA component takes 6 months to resorb and the polypropylene

is left to strengthen the fascia; whilst the onlay patch which is the anterior implant is 75% PLLA and 25%

polypropylene.

Intended purpose

The device is intended for abdominal reinforcement including inguinal and femoral hernias.

Variant information

Diameter (cm) 4DDOM24GSR

Diameter (cm) 4DDOM30GSR

Diameter (cm) 4DDOM38GSR

Diameter (cm) Size - 24 - 38 (Dome)

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 09.11.2017 at 07:58:58 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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