Stimulator [13762] (Cancelled from the ARTG under paragraphs 41GN(1)(b) and 41GN(1)(f))
Product name
Stimulator [13762]
Sponsor
ARTG
190674
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under paragraphs 41GN(1)(b) and 41GN(1)(f)
Grounds for regulatory action
The certifications made by the sponsor under section 41FD in relation to the inclusion of the kind of device in the ARTG are incorrect in a material particular and the sponsor failed to comply with the conditions of inclusion stipulated under paragraph 41FN(3).