Cereform Optima Silicone Gel-Filled Breast Implant (Suspended from the ARTG under s. 41GA(1)(b) of the Act)
Product name
Cereform Optima Silicone Gel-Filled Breast Implant
ARTG
165462
Date action takes effect
Lapse date
Compliance action
Medical device suspension
Type of action
Suspended from the ARTG under s. 41GA(1)(b) of the Act
Grounds for regulatory action
As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.
This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.