This article was originally published in The Gray Sheet
Executive SummaryCompany's premarket approval application for the absorbable collagen hemostatic sponge is "approvable," the company announces Aug. 12. FDA has asked Portland, Maine-based Bioetica, Inc. to "submit additional information" within the next few weeks. The company notes that the sponge has "been evaluated in a multi- center clinical trial for use in a variety of surgical procedures as an adjunct for hemostasis when control by ligature or conventional procedures is ineffective or impractical." The sponge is manufactured by Bioetica's Lyon, France-based parent company, Coletica, SA
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