MDEC meeting 2007/1, 23 March 2007

Medical Device Evaluation Committee

Meeting report

The 2007/1 (13th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 23 March 2007. The main points of discussion included:

• an application by Medtronic Australasia Pty Ltd for the provision of a conformity assessment certificate for the Talent Abdominal Aneurysm and Aorto-uni-iliac Stent Graft with Xcelerant Delivery to be used to repair abdominal aortic aneurysms.
• an application by Medicult Australia Pty Ltd for the provision of a conformity assessment certificate for Medicult IVF Solutions to be used sequentially during the In Vitro Fertilisation (IVF) process to optimise infertility treatment outcomes.
• an application by William A Cook Australia Pty Ltd for the provision of a conformity assessment certificate for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.
• consideration of the activity reports from the MDEC subcommittees.

The 2007/2 MDEC meeting is proposed for 8 June 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 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.

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