Veritas

Main information

  • Trade name:
  • Veritas Collagen Matrix - Multi-purpose surgical mesh, collagen
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Veritas Collagen Matrix - Multi-purpose surgical mesh, collagen
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219240
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219240

Baxter Healthcare Pty Ltd - Veritas Collagen Matrix - Multi-purpose surgical mesh, collagen

ARTG entry for

Medical Device Included Class III

Sponsor

Baxter Healthcare Pty Ltd

Postal Address

PO Box 88,TOONGABBIE, NSW, 2146

Australia

ARTG Start Date

15/01/2014

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

Synovis Surgical Innovations (A Div of Synovis

Life Technologies Inc)

2575 University Avenue

ST PAUL, MN, 55114

United States Of America

Products

1. Veritas Collagen Matrix - Multi-purpose surgical mesh, collagen

Product Type

Single Device Product

Effective date

4/05/2017 3:50:19 PM

GMDN

60907 Multi-purpose surgical mesh, collagen

Functional description

Veritas Collagen Matrix is an implantable biological mesh comprised of non-crosslinked bovine

pericardium which allows for neo-collagen formation and neo-vascularization of the implanted

device and permits replacement of the device with host tissue, or remodeling. Veritas Collagen

Matrix also minimizes tissue attachment to the device in case of direct contact with viscera.

Intended purpose

Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies:

abdominal and thoracic wall repair, muscle flap reinforcement, and repair of hernias (e.g., diaphragmatic,

femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). Veritas Collagen Matrix minimizes

tissue attachment to the device in case of direct contact with viscera.

Variant information

Size (cm) 2 x 8cm to 12 x 25cm

Specific Conditions

The person in relation to whom the Veritas Collagen Matrix (GMDN: Tissue reconstructive material, biological [33525]) (the Device) is included in the

ARTG (the sponsor) collects data on the use of the Device, including any complaints (specifically any expected and foreseeable side effects that are

documented in the manufacturer's Instructions for Use or Labelling) and other adverse events associated with the Device. The sponsor must provide this

information to the Office of Product Review of the Therapeutic Goods Administration (TGA) every six months for three years commencing on the date of

inclusion of the Device in the ARTG (until and unless advised otherwise). The information should be provided in the format of the report as specified in

the Attachment A to the Notice made under sections 41FF and 41FO of the Therapeutic Goods Act 1989 in relation to the Device, dated 14 January

2014 (refer FILE 2013/024360).

© 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 08:09:49 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