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: cryogenic spray, cutaneous
ARTG number: 197620
Sponsor: Device Technologies Australia Pty Ltd
Manufacturer: Occam Design (USA)
Decision Date: 16 July 2013
Date of Effect: 31 August 2013
Reason
The certifications made in the application to include this kind of device in the Register under section 41FD(c) of the Act is not correct in relation to the classification of this kind of device. The classification of the medical device in the ARTG Entry is incorrect.
(Signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
16 July 2013