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CYTYC THINPREP PROCESSOR WILL UNDERGO NEW CLINICALS

This article was originally published in The Gray Sheet

Executive Summary

CYTYC THINPREP PROCESSOR WILL UNDERGO NEW CLINICALS following withdrawal of the company's premarket approval application for the device in March, the company said. Cytyc hopes to begin the new trials this year and to file a new PMA in 1995. Cytyc withdrew the PMA after FDA investigators delivered an FDA-483 report raising "significant questions" about the conduct of the firm's PMA study. During inspections Of the five clinical trial sites, conducted Feb. 14-17 and Feb. 28, FDA found deficiencies in the monitoring, protocols, and recordkeeping for the 3,218-patient study.
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