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TriPath Imaging, Inc.

This article was originally published in The Gray Sheet

Executive Summary

PMA supplement is submitted to FDA covering use of the AutoPap automated primary Pap smear slide screening system with cytology samples prepared using the Prep automated, liquid-based Pap smear sample preparation system. TriPath is the new name for the recent combination of Prep system developer AutoCyte and AutoPap maker NeoPath under a June merger completed Oct. 1 (1"The Gray Sheet" June 14, p. 15). The Prep system was approved June 17 to replace conventional Pap smear preparation in primary screening for cervical cancer but not specifically for use with AutoPap, which was approved for initial screening of conventional slides in May 1998

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