Barrigel - Radiotherapy protection spacer

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Palette Life Sciences Australia Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
339926

Public Summary

Summary for ARTG Entry:

339926

Palette Life Sciences Australia Pty Ltd - Barrigel - Radiotherapy protection spacer

ARTG entry for

Medical Device Included Class III

Sponsor

Palette Life Sciences Australia Pty Ltd

Postal Address

PO Box 506, Narrabeen, NSW, 2101

Australia

ARTG Start Date

21/07/2020

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

Palette Life Sciences

27 E Cota Street Suite 402

Santa Barbara, CA, 93101

United States Of America

Products

1 . Barrigel - Radiotherapy protection spacer

Product Type

Single Device Product

Effective Date

21/07/2020

GMDN

60424 Radiotherapy protection spacer

Functional

Description

Barrigel is a sterile, transparent, biodegradable gel of stabilized hyaluronic acid of non-animal origin, supplied in a glass syringe.

Barrigel acts by adding volume to the tissue, thereby mechanically creating an increased distance between the prostate and the

anterior rectal wall. The product degrades over time.

Intended Purpose

Barrigel is used to increase the distance between the prostate and the anterior rectal wall, with the intent to decrease radiation dose

delivered to the rectum when treating prostate cancer with radiation.

Variant information

Nil variant (as 1 device) 3mL

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 22.07.2020 at 07:58:56 AEST

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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