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General and Plastic Surgery Devices Panel

This article was originally published in The Gray Sheet

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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