Amplatzer Postmarket Study Should Address Age, Device Size Issues - Panel
This article was originally published in The Gray Sheet
Executive Summary
FDA approval of AGA Medical's Amplatzer septal occluder should include a requirement for a five-year postmarket study of patients under 10 years of age who receive the device, the agency's Circulatory System Devices Panel recommended at its Sept. 10 meeting in Gaithersburg, Maryland.
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