Summary for ARTG Entry:
Allergan Australia Pty Ltd - BRST Round Smooth Responsive gel filled breast implants - Prosthesis,
internal, mammary, gel filled
ARTG entry for
Medical Device Included Class III
Allergan Australia Pty Ltd
Locked Bag 1514,PYMBLE, NSW, 2073
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.
Marlow International Parkway Marlow
Bucks, , SL7 1YL
1. BRST Round Smooth Responsive gel filled breast implants - Prosthesis, internal, mammary, gel filled
Single Device Product
36197 Prosthesis, internal, mammary, gel filled
BRST Round Smooth 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 for breast augmentation or reconstructive mammaplasty
Product name (see guidance docs) BRST BSF (Full
Diameter (cm) 8.6 - 16.9 cm
Width (cm) 2.2 - 5.3cm
Size 100 - 800g
Product name (see guidance docs) BRST BSM
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:24:19 AEDT
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