Prosthesis, incontinence (Cancelled from the ARTG under s.41GN(1)(b))
Product name
Prosthesis, incontinence
Sponsor
ARTG
132657
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s.41GN(1)(b)
Grounds for regulatory action
As the sponsor did not provide sufficient 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).
Decision status
Internal review confirmed cancellation decision. Application made by sponsor for AAT review of internal decision to confirm cancellation.
The cancellation has been confirmed by the Administrative Appeals Tribunal on 29 November 2018. The full decision is available at: TFS Manufacturing Pty Ltd and Minister for Health [2018] AATA 4456 (29 November 2018).