MDEC meeting 2008/3, 5 September 2008

Medical Device Evaluation Committee

Meeting report

The 2008/3 (19th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 5 September 2008. The main points of discussion included:

• an application by Boston Scientific Pty Ltd for the provision of a variation to the conformity assessment certificate for the Taxus Liberte Paclitaxel-Eluting Coronary Stent for improving the luminal diameter and reducing restenosis within the stent and the treatment of de novo lesions in native coronary arteries 'in patients with and without concomitant diabetes mellitus'.
• consideration of the activity reports from the MDEC Subcommittees and Expert Advisory Groups.

The 2008/4 MDEC meeting is proposed for 5 December 2008.

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.