Monomax

Main information

  • Trade name:
  • Monomax - Suture, polybutester
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Monomax - Suture, polybutester
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219418
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219418

B Braun Australia Pty Ltd - Monomax - Suture, polybutester

ARTG entry for

Medical Device Included Class III

Sponsor

B Braun Australia Pty Ltd

Postal Address

PO Box 6221,BAULKHAM HILLS DC, NSW, 2153

Australia

ARTG Start Date

21/01/2014

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

B Braun Surgical SA

Carretera De Terassa 121

RUBI (BARCELONA), , E-08191

Spain

Products

1. Monomax - Suture, polybutester

Product Type

Single Device Product

Effective date

21/01/2014

GMDN

17245 Suture, polybutester

Functional description

Monomax is an extra long-term absorbable monofilament synthetic suture made of poly-4 hydroxybutyrate.

Monomax degrades by hydrolysis and enzymatic reaction and provides a predictable and reliable longterm

absorption. It sustains 50 % of its original strength for more than 3 months and can provide sufficient

wound support during the healing process of the abdominal wall.

Intended purpose

Monomax is intended for use in general soft tissue approximation, especially when the use of an

absorbable monofilament suture with an extended wound support up to 15 weeks indicated. A typical

indication is the abdominal wall closure after midline incision using a continuous, all layer suture technique.

Variant information

Suture, needle, physical attributes 1/2 circle

Suture, needle, physical attributes 5/8 circle

Suture, needle, physical attributes round bodied

needle

Suture, needle, physical attributes trocar point

Suture, needle, physical attributes hook

Suture, needle, physical attributes short cutting point

Suture, needle, physical attributes blunt point

Quantity/pack 4 to 24

Suture, gauge 2/0 to 1 USP or 3-4 mm

Length (cm) 70 to 200

Suture, colour Violet

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 22.11.2017 at 11:36:17 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