S.T.A.R, Mobile-bearing total ankle prosthesis (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
S.T.A.R, Mobile-bearing total ankle prosthesis
Sponsor
ARTG
237795
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GN(1) of the Act
Grounds for regulatory action
As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a).