SAN LUIS OBISPO, Calif.--(BUSINESS WIRE)--Dec. 12, 2005--FzioMed, Inc. announced today that it has submitted its third Pre-Market Approval (PMA) application module to the U.S. Food and Drug Administration for the company’s Oxiplex/SP Adhesion Barrier Gel. Four modules are required to complete FzioMed’s PMA application for approval to market Oxiplex/SP Gel in the United States. The three modules filed thus far contained documentation and data related to the design, development, pre-clinical testing, quality assurance and manufacturing of Oxiplex/SP Gel. The fourth, and final, module will include the clinical results from the Oxiplex/SP Gel pivotal clinical trial currently in progress in the U.S. FDA previously granted expedited review status to FzioMed for its Oxiplex/SP PMA application.
