Summary for ARTG Entry:
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
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 AIMD
- 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 Patient Controlled Tissue Expander - Remotely-controlled tissue expander
Medical device system
59370 Remotely-controlled tissue expander
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.
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.
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
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:05:03 AEDT
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