Aeroform

Main information

  • Trade name:
  • Aeroform Patient Controlled Tissue Expander - Remotely-controlled tissue expander
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Aeroform Patient Controlled Tissue Expander - Remotely-controlled tissue expander
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216704
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216704

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Aeroform Patient Controlled Tissue Expander -

Remotely-controlled tissue expander

ARTG entry for

Medical Device Included AIMD

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

30/10/2013

Product category

Medical Device AIMD

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

Airxpanders

1047 Elwell Court

Palo Alto, CA, 94303

United States Of America

Products

1. Aeroform Patient Controlled Tissue Expander - Remotely-controlled tissue expander

Product Type

Medical device system

Effective date

30/10/2013

GMDN

59370 Remotely-controlled tissue expander

Functional description

The tissue expander contains a reservoir of compressed C02 which is released within the expander by

using a remote control resulting in gradual expansions. The expander has a textured, outer silicone shell

and a non-distensible inner liner which are anatomically shaped to allow for directional expansion in the

lower, anterior pole. A receiving antenna and electronics located within expander enable communication

with external controller.

Intended purpose

The AeroForm™ Tissue Expander is intended for use in post-mastectomy patients to develop tissue

coverage for the placement of a silicone or saline breast implant. The AeroForm™ Tissue Expander is for

temporary subcutaneous or sub-muscular implantation and is not intended for use beyond six months.

Variant information

Volume (mL) 400

Volume (mL) 600

Volume (mL) 800

Width (cm) 12.5

Width (cm) 15.5

Height (cm) 11.0

Height (cm) 12.5

Height (cm) 14.0

Width (cm) 14.0

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 02.12.2017 at 05:05:03 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