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Silicone gel-filled breast implant, smooth-surface (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Silicone gel-filled breast implant, smooth-surface / 64081
Sponsor
ARTG details
- 282777
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GN(1)
Grounds for regulatory action
The sponsor failed to comply with conditions of inclusion for the Devices in the ARTG (see paragraph 41GN(1)(b) of the Act).
Certifications made under section 41FD of the Act in relation to the application for inclusion of the Devices in the ARTG are incorrect, or are no longer correct, in a material particular (see paragraph 41GN(1)(f) of the Act).