BRST

Main information

  • Trade name:
  • BRST Round Microcell Textured Responsive gel filled breast implants - Prosthesis, internal, mammary, gel filled
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • BRST Round Microcell Textured Responsive gel filled breast implants - Prosthesis, internal, mammary, gel filled
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218869
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218869

Allergan Australia Pty Ltd - BRST Round Microcell Textured Responsive gel filled breast implants -

Prosthesis, internal, mammary, gel filled

ARTG entry for

Medical Device Included Class III

Sponsor

Allergan Australia Pty Ltd

Postal Address

Locked Bag 1514,PYMBLE, NSW, 2073

Australia

ARTG Start Date

2/01/2014

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

Allergan

Marlow International Parkway Marlow

Bucks, , SL7 1YL

Products

1. BRST Round Microcell Textured Responsive gel filled breast implants - Prosthesis, internal, mammary, gel

filled

Product Type

Single Device Product

Effective date

2/01/2014

GMDN

36197 Prosthesis, internal, mammary, gel filled

Functional description

BRST Round Textured Responsive Single Lumen breast implants are made of silicone elastomer,

pre-filled with cohesive silicone gel to simulate natural breast tissue. The intrashiel shell features a barrier

coat between two layers of silicone elastomers to minimise gel diffusion.

Intended purpose

Intended for breast augmentation or reconstructive mammaplasty

Variant information

Diameter (cm) 8.7 - 14.5 cm

Product name (see guidance docs) BRST RLP (Low

Profile)

Product name (see guidance docs) BRST RMP

(Moderate Profile)

Product name (see guidance docs) BRST RHP

(High Profile)

Product name (see guidance docs) BRST BRM

(Moderate Profile)

Size 110 - 605 g

Width (cm) 2.6 - 5.8 cm (projection)

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 10.11.2017 at 09:04:49 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