AeroForm™

Main information

  • Trade name:
  • AeroForm™ Tissue Expander System Dosage Controller Kit - Remotely-controlled tissue expander remote control
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • AeroForm™ Tissue Expander System Dosage Controller Kit - Remotely-controlled tissue expander remote control
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216653
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216653

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - AeroForm™ Tissue Expander System Dosage

Controller Kit - Remotely-controlled tissue expander remote control

ARTG entry for

Medical Device Included Class III

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

28/10/2013

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

Airxpanders

1047 Elwell Court

Palo Alto, CA, 94303

United States Of America

Products

1. AeroForm™ Tissue Expander System Dosage Controller Kit - Remotely-controlled tissue expander remote

control

Product Type

Single Device Product

Effective date

28/10/2013

GMDN

59371 Remotely-controlled tissue expander remote control

Functional description

Hand-held remote control contains batteries, antenna & circuitry to provide power to expander. Coded

instructions from controller cause programmed release of CO2 resulting in expansion. Controller contains

software that tracks dosing activity & volume of expander. Dose is amount of CO2 released within

expander each time controller button is pressed. Controller is pre-programmed to limit dosing , but

physician can administer doses above programmed patient limits by using Physician Master Key.

Intended purpose

A battery-powered device designed to remotely control expansion of an implanted inflatable tissue

expander and intended to be operated intermittently by the patient or physician over a prescribed period to

develop tissue coverage prior to the placement of a permanent breast implant. The operator sends a

coded instruction by telemetry to release a controlled volume of gas contained in a cylinder within the

implant to cause the expansion. It is typically paired with the implant, which contains a programmable

identification (ID) chip, in the operating room during implantation. This is a reusable device intended for

single-patient use.

Variant information

Nil variant (as 1 device) Nil

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 05:05:36 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