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Cardima dispute headed to panel

This article was originally published in The Gray Sheet

Executive Summary

FDA's Medical Device Dispute Resolution Panel will convene April 19 in Gaithersburg, Md., to hear Cardima's arguments for PMA approval of its Revelation Tx atrial fibrillation device. An advisory panel voted unanimously to reject the application in 2003, citing study design problems (1"The Gray Sheet" June 2, 2003, p. 3). A dispute is eligible for review by the panel only if the matter is based on "sound scientific grounds," and if "sufficient effort" has been made to resolve the complaint through less formal mechanisms...

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