Coated ankle talus prosthesis (Cancellation from the ARTG under paragraph 41GN(1)(b) of the Act)
Product name
Coated ankle talus prosthesis
Sponsor
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under paragraph 41GN(1)(b) of the Act
Grounds for regulatory action
The sponsor failed to comply with conditions to which the inclusion of the Devices in the ARTG is subject (paragraph 41GN(1)(b) of the Act).
The sponsor did not provide sufficient information to substantiate compliance with the Essential Principles or have procedures in place to ensure that such information can be obtained from the manufacturer of the Device within 20 working days (see subparagraph 41FN(3)(a) of the Act).
The sponsor did not provide sufficient evidence of compliance with adverse event reporting requirements (see subparagraph 41FN(3)(d) of the Act).