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Advanced Tissue Sciences

This article was originally published in The Gray Sheet

Executive Summary

FDA requests clarification and additional information from ATS regarding its premarket approval application for Dermagraft for the treatment of diabetic foot ulcers, according to a Feb. 21 company release. The PMA was submitted in August 2000. Upon approval, Dermagraft will be marketed by Smith & Nephew (1"The Gray Sheet" Aug. 28, 2000, In Brief)

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Firm announces submission of a premarket approval application to FDA for its Dermagraft wound dressing to treat diabetic foot ulcers. Clinical trials for the Dermagraft, which will be marketed by Smith & Nephew, indicate that the product heals significantly more ulcers than control treatment, the firm says in an Aug. 25 release. Competitor Organogenesis received an approvable recommendation from FDA's General and Plastic Surgery Devices panel in May (1"The Gray Sheet" May 15, 2000, p. 8)

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