MDEC meeting 2007/3, 31 August 2007

Medical Device Evaluation Committee

Meeting report

The 2007/3 (15th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 31 August 2007. The main points of discussion included:

• an application by Sirtex Medical Limited for the provision of a conformity assessment certificate for the SIR-Spheres and Delivery Apparatus for use as 'Selective Internal Therapy' to patients with advanced inoperable liver cancer.
• an application by Vitrolife Sweden AB for the provision of a conformity assessment certificate for Steen Solution (lung perfusion solution) for use to assess donor lungs in-vitro, for lung transplantation.
• consideration of the activity reports from the MDEC Subcommittees and Expert Advisory Groups.

The 2007/4 MDEC meeting is proposed for 7 December 2007.

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 registration

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.

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