MDEC meeting 2006/1, 24 March 2006

Medical Device Evaluation Committee

Meeting report

The 2006/1 (10th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 24 March 2006. The main points of discussion included -

• an application by Inamed Australia Pty Ltd for the provision of a conformity assessment certificate for the Juvederm® range of dermal fillers to be used as dermal filler for the correction of defects such as wrinkles.
• an application by Medtronic Australasia Pty Ltd for the provision of a conformity assessment certificate for the Endeavour Coronary Stent System for the correction of heart defects by improving luminal diameters as an adjunct to coronary interventions and reducing restenosis.
• an application by Boston Scientific Pty Ltd for the provision of a conformity assessment certificate for the Taxus Liberté Paclitaxel-Eluting Coronary Stent System for improving luminal diameter and reducing restenosis within the stent and at the stent edges for the treatment of de novo lesions in native coronary arteries.
• an application by the Donor Tissue Bank of Victoria to register Freeze Dried Cancellous Milled Allograft Bone Matrix (CBM) and Demineralised Freeze Dried Milled Allograft Bone Matrix (DBM) for use in structural repair and reconstruction to repair bone fractures, joint and spinal arthrodeses and revision arthroplasties.
• the application by Clinical Cell Culture (C3) Operations Pty Ltd for a conformity assessment certificate for the Recell Harvesting Device intended for the rapid epithelial cover of small areas for burn injuries.
• the issue of IVF media and preclinical testing for toxicity.
• Recommendations from "out-of-session" MDEC teleconferences.

The 2006/2 MDEC meeting is proposed for 16 June 2006.

Summary of key resolutions

NOTE: This summary has been prepared to provide rapid advice of the Resolutions made by the Medical Device Evaluation Committee (MDEC) at its recent meeting. It should not be assumed that recommendations made to the TGA represent the decisions of the TGA.

Device registrations

MDEC resolved that the following medical device applications should be approved, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the TGA. These recommendations for approval may be subject to specific conditions.

Minutes of the previous meeting

RES NO. 2006/1

The minutes of the 2005/4 (9th) meeting of the Medical Device Evaluation Committee (MDEC) are accepted and ratified as a true record, subject to minor amendments.

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