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Data Deficiencies Derail Lifecore Intergel Liquid Adhesion Barrier PMA

This article was originally published in The Gray Sheet

Executive Summary

Higher than expected infection rates, pending safety data and lingering questions over clinical efficacy prompted FDA's General and Plastic Surgery Devices Panel to recommend against approval of Lifecore Biomedical's Intergel adhesion prevention barrier solution in a 5-2 vote during a Jan. 12 meeting in Rockville, Maryland.
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