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)(c) of the Act:
ARTG entry of a kind of medical device: Surgical Procedure Kit, dental, implant/prosthesis
ARTG number: 202504
Sponsor: Osstem Australia Pty Ltd
Manufacturer: Osstem Implant Co Ltd (Korea- Republic of)
Date of Decision: 23 July 2013
Date of Effect of Cancellation: 30 August 2013
Reason:
Section 41GN(1) (c) of Therapeutic Goods Act 1989 - The sponsor of the device failed to comply with a notice given to the sponsor by the Secretary under section 41JA of the Act.
(signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
23 July 2013