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This article was originally published in The Gray Sheet

Executive Summary

Company appeals to have the Lea's Contraceptive Diaphragm (formerly Lea's Shield) reclassified to Class II in a Sept. 9 letter to FDA. On Aug. 14, the agency rejected a June 510(k) application for the device, maintaining it is not substantially equivalent to a Class II diaphragm. Yama included in the application the results of a 300-patient trial comparing use of the device with and without spermicide. In 1996, an FDA panel reviewed the results as part of a PMA application, finding the device safe and effective, but refused to recommend approval due to the small number of trial subjects



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