Summary for ARTG Entry:
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
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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.
1047 Elwell Court
Palo Alto, CA, 94303
United States Of America
1. AeroForm™ Tissue Expander System Dosage Controller Kit - Remotely-controlled tissue expander remote
Single Device Product
59371 Remotely-controlled tissue expander remote control
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.
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
Nil variant (as 1 device) Nil
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.
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