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This article was originally published in The Gray Sheet

Executive Summary

Submits an amendment to its June 1997 premarket approval application for use of its Prep sample preparation system in cervical cancer screening. The amendment follows a request by FDA for more information, including additional analysis and presentation of existing clinical data, to demonstrate sensitivity to low grade, high grade, and cancerous lesions, the firm states. A "small nonclinical internal study" also was included in the amendment. The PMA will not need to be reviewed by an agency advisory panel ("The Gray Sheet" July 14, 1997, p. 8)...

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