Urogynaecological surgical mesh (Prosthesis, internal, bladder, urinary, mesh) (Cancelled from the ARTG under s. 41GN(1)(b))
Product name
Urogynaecological surgical mesh (Prosthesis, internal, bladder, urinary, mesh)
Sponsor
ARTG
200723
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)(i).