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Administered by: Health
Published Date 16 Aug 2013

COMMONWEALTH OF AUSTRALIA

Department of Health and Ageing
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

CANCELLATION OF ENTRIES FOR KINDS OF MEDICAL DEVICES

FROM THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS

PUBLICATION UNDER SECTION 41GP OF THE ACT

I, Rodolfo Ferrari, delegate of the Secretary of the Department of Health and Ageing for the purposes of section 41GP of the Therapeutic Goods Act 1989 (the Act), hereby publish under section 41GP of the Act particulars of the cancellation of the following entry of a kind of medical device from the Australian Register of Therapeutic Goods (the ARTG).

ARTG number:                   208813

Kind of medical device:  CAD/CAM unit, orthopaedic [41018]

Sponsor:                                 Biomet Australia Pty Ltd

Manufacturer:                     Biomet Orthopaedics Inc (United States of America)

Decision Date:                    16 August 2013

Date of effect of cancellation:   23 September 2013

Reasons for the cancellation: 

The appropriate conformity assessment procedures had not been applied to the device by the

manufacturer,  therefore the declaration made under 41FD(f)at the time of the application is incorrect.

The ARTG Entry is cancelled under Section 41GN(1)(f) of the Act.

 

(Signed by)

Rodolfo Ferrari

Delegate of the Secretary of the Department of Health and Ageing

 

16 August 2013