Wright Medical (WMGI) Reports FDA Approvable of Augment Bone Graft, Lowers FY14 Sales Guidance (StreetInsider)
Wright Medical Group, Inc. (NASDAQ: WMGI) today announced that its BioMimetic subsidiary has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its Premarket Approval Application (PMA) for Augment® Bone Graft. The approvable letter indicates that FDA determined Augment® Bone Graft to be safe and effective as an alternative to autograft for ankle and/or hindfoot fusion indications and is approvable subject to customary preapproval facilities inspections....
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