CryoLife BioGlue PMA Clears FDA Panel With Minimal Conditions
This article was originally published in The Gray Sheet
Executive Summary
One member of FDA's Circulatory System Devices Panel suggested that the agency look into the number of transfusions performed when surgeons use CryoLife's BioGlue surgical adhesive, but stopped short of recommending it as a condition of approval during the panel's Sept. 11 review of the product.