PUBLICATION OF CANCELLATION OF ENTRIES FOR KINDS OF MEDICAL DEVICES
FROM THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS
SECTION 41GP OF THE THERAPEUTIC GOODS ACT 1989
I, Rodolfo Ferrari, delegate of the Secretary to the Department of Health and Ageing for the purposes of section 41GP of the Therapeutic Goods Act 1989 (the Act), hereby publish particulars of the cancellation of the following entry of a kind of medical device from the Australian Register of Therapeutic Goods under subsection 41GN(1)(f) of the Act:
ARTG entry of a kind of medical device: Stimulator, <specify>
ARTG number: 193081
Sponsor: Shuzi Australia Pty Ltd
Manufacturer: Skytyan Inc (USA)
Date cancelled: 23 April 2013
Date of effect of cancellation: 31 May 2013
Reason:
The certifications made in the device application under section 41DA of the Act to the effect that the product is a medical device is no longer correct because all therapeutic claims have been removed from the product information and promotional material of the product. The product no longer meets the definition of a medical device and the ARTG Entry is cancelled.
(Signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
23 April 2013