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Artificial Embolization Device Downclassification To Be Discussed By Panel

This article was originally published in The Gray Sheet

Executive Summary

Safety and effectiveness data on artificial embolization devices will be presented to FDA's Neurological Devices Panel at its June 12 meeting to provide input to the agency on the downclassification of the Class III preamendments devices. The meeting will be held at FDA's Corporate Building in Rockville, Maryland, beginning at 10:30 a.m.

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