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Panel to Discuss S&E of Atrial Septal Defect Occluders

03/28/2012

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 5/24 from 8 a.m. to 6 p.m. at the Hilton Washington, DC North/Gaithersburg, Montgomery Rm., 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss current knowledge about the safety and effectiveness of the Amplatzer ASO device & Gore Helex ASD Occluder as transcatheter atrial septal defect occluders used for the closure of secundum atrial septal defects. The devices were introduced into the U.S. market in 2001 and 2006 respectively, and with more widespread use, more adverse event information is available. The purpose of discussion of these events is: (1) To discuss the significance of these events in the overall context of the disease and existing treatment options; (2) to discuss whether additional measures should be taken to improve protection of the public health (e.g., additional study and/or data analyses, labeling changes); and (3) to communicate to patients and physicians what is and is not known about device treatment options. Contact Jamie Waterhouse, (301) 796-3063. To view this notice, click here.

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