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General and Plastic Surgery Devices Panel

This article was originally published in The Gray Sheet

Executive Summary

Committee will meet May 8 to discuss and vote on a premarket approval application for an interactive wound and burn dressing to treat diabetic foot ulcers. Organogenesis submitted a PMA for its Apligraf living skin construct for the indication in December; Advanced Tissue Sciences is pursuing the indication for its Dermagraft product. A PMA for an in situ polymerizable surgical mesh to seal air leaks following thoracic cavity surgery also will be discussed
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