Device Technologies Australia Pty Ltd - Prosthesis, internal, chin (Suspension from the ARTG under s.41GA (1)(b))
Product name
Device Technologies Australia Pty Ltd - Prosthesis, internal, chin
Sponsor
ARTG
144268
Date action takes effect
Lapse date
Compliance action
Medical device suspension
Type of action
Suspension from the ARTG under s.41GA (1)(b)
Grounds for regulatory action
As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are 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 proposed to suspended the entries for a period not exceeding 6 months.
A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).