Summary for ARTG Entry:
Allergan Australia Pty Ltd - BRST Round Microcell Textured Cohesive 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 Microcell Textured Cohesive gel filled breast implants - Prosthesis, internal, mammary, gel
Single Device Product
36197 Prosthesis, internal, mammary, gel filled
BRST Round Textured Cohesive 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 CLP (Low
Product name (see guidance docs) BRST CHP
Product name (see guidance docs) BRST CXP
(Extra High Profile)
Product name (see guidance docs) BRST CMP
Width (cm) 2.6 - 6.6 cm
Size 80 - 800g
Diameter (cm) 7.6 - 16.9 cm
Product name (see guidance docs) BRST BCM
Product name (see guidance docs) BRST BCX
(Extra Full Profile)
No Specific Conditions included on Record
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Produced at 10.11.2017 at 02:49:46 AEDT
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