Summary for ARTG Entry:
Baxter Healthcare Pty Ltd - Veritas Collagen Matrix - Multi-purpose surgical mesh, collagen
ARTG entry for
Medical Device Included Class III
Baxter Healthcare Pty Ltd
PO Box 88,TOONGABBIE, NSW, 2146
ARTG Start Date
Medical Device Class III
- 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.
Synovis Surgical Innovations (A Div of Synovis
Life Technologies Inc)
2575 University Avenue
ST PAUL, MN, 55114
United States Of America
1. Veritas Collagen Matrix - Multi-purpose surgical mesh, collagen
Single Device Product
4/05/2017 3:50:19 PM
60907 Multi-purpose surgical mesh, collagen
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.
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.
Size (cm) 2 x 8cm to 12 x 25cm
The person in relation to whom the Veritas Collagen Matrix (GMDN: Tissue reconstructive material, biological ) (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
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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.
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