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In Brief: Circulatory System Devices Panel

This article was originally published in The Gray Sheet

Executive Summary

Circulatory System Devices Panel: Meeting Oct. 24 at the Marriott Washingtonian Center in Gaithersburg, Maryland to provide FDA with input on the design of clinical trials to support premarket approval applications for devices intended to treat atrial septal defects, patent foramen ovale, and patent ductus arteriosus. Issues "of particular concern," FDA says, include appropriate controls, appropriate safety and efficacy measures, and the point in time at which these measure should be made. For further information contact FDA's John Stuhlmuller at 301/443-8243...



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