NOTE: This report has been prepared to provide rapid advice of the Resolutions of the Advisory Committee on Medical Devices (ACMD) at its recent meeting. It should not be assumed that advice given to the TGA represents the decisions of the TGA.
The 2011/1 meeting of the ACMD was held on 18 March 2011. ACMD supported the approval of the following medical device applications, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the TGA. This advice on approval may be subject to specific conditions.
2011/1 meeting report and resolutions
Product: Zilver PTX Drug-Eluting Peripheral Stent
William A Cook Australia Pty Ltd
- an application by William A Cook Australia Pty Ltd for the provision of a conformity assessment certificate for the Zilver PTX Drug-Eluting Peripheral Stent intended for use in the treatment of symptomatic vascular disease of above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 9 mm.
Product: QUADROX-i with Bioline Coating (blood oxygenator)
Maquet Australia Pty Ltd
- an application by Maquet Australia Pty Ltd for the provision of a conformity assessment certificate for 13 devices coated with Bioline Coating (catheters, cannulae, oxygenators, heat exchangers, arterial filters, blood reservoirs, blood pumps and tubing sets), intended for use to oxygenate the blood and to remove carbon dioxide from the blood, and to regulate the blood temperature in an extracorporeal circulation during a cardiopulmonary bypass procedure.