Cohera Medical, Inc.® Completes Fourth and Final Module in the Premarket Approval (PMA) Application for TissuGlu® Surgical Adhesive

PITTSBURGH, Nov. 19, 2013 -- PITTSBURGH, Nov. 19, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today it has submitted its fourth and final module for TissuGlu® Surgical Adhesive in the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA)."We are pleased to have submitted the final module of the PMA application for TissuGlu," said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. "This module culminates substantial work by the Cohera team and our investigational partners."A modular PMA submission is one in which the contents of a PMA are broken into several clearly defined parts or modules. These modules are submitted separately over time and comprise a complete PMA when all of them have been submitted. FDA reviews each module separately which may allow for a more efficient review when the last components are submitted because much of the review work will have already been completed. Cohera Medical has already successfully submitted the first three modules of the PMA application: biocompatibility, design control and manufacturing.The fourth and final module submitted is comprised of data from Cohera Medical's 'No Drain' study, confirming that TissuGlu is a clinically superior alternative to closed-suction drains for fluid management in large flap procedures such as abdominoplasty. In ...
Source: Medical Hemostat - Category: Technology Consultants Authors: Source Type: blogs