PITTSBURGH, Jan. 6, 2015 /PRNewswire/ -- Cohera Medical, Inc. ®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) that the pending Premarket Approval Application (PMA) for its TissuGlu® Surgical Adhesi..."> PITTSBURGH, Jan. 6, 2015 /PRNewswire/ -- Cohera Medical, Inc. ®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) that the pending Premarket Approval Application (PMA) for its TissuGlu® Surgical Adhesi..." /> PITTSBURGH, Jan. 6, 2015 /PRNewswire/ -- Cohera Medical, Inc. ®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) that the pending Premarket Approval Application (PMA) for its TissuGlu® Surgical Adhesi..." />

Cohera Medical, Inc. ® Receives PMA Approvable Letter from U.S. FDA for TissuGlu® Surgical Adhesive

< span style= " color: #444444; font-family: Verdana, sans-serif; " > PITTSBURGH, Jan. 6, 2015 /PRNewswire/ -- Cohera Medical, Inc. ®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) that the pending Premarket Approval Application (PMA) for its TissuGlu® Surgical Adhesive is Approvable. & nbsp;The receipt of the Approvable Letter means that the FDA has largely approved all parts of the PMA. The Company expects to work with the FDA to reach a final approval on the application within a few weeks. < /span > < br / > < span style= " color: #444444; font-family: Verdana, sans-serif; " > < br / > < /span > < span style= " color: #444444; font-family: Verdana, sans-serif; " > " The receipt of the PMA Approvable Letter is a truly significant milestone for the Company, " said Patrick Daly, Cohera Medical President and CEO. " We are excited about the pending approval for TissuGlu and are looking forward to making TissuGlu available to surgeons and patients throughout the United States. " < /span > < br / > < span style= " color: #444444; font-family: Verdana, sans-serif; " > < br / > < /span > < span style= " color: #444444; font-family: Verdana, sans-serif; " > TissuGlu is indicated for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in abdominoplasty. & nbsp;Upon approval, TissuGlu will be the first internal s...
Source: Medical Hemostat - Category: Medical Equipment Authors: Source Type: blogs