Prosthesis, internal incontinence (Cancelled from the ARTG under s41GN (1)(b))
Product name
Prosthesis, internal incontinence
Sponsor
Date action takes effect
Compliance action
Medical device cancellation - certain devices within an entry
Type of action
Cancelled from the ARTG under s41GN (1)(b)
Grounds for regulatory action
Cancelled by Secretary - 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 s41FN(3)(a).
Device names
Safyre T, Safyre T plus, Safyre VS