Rapid PMA (premarket approval application) review for Fusion's FloSeal:
This article was originally published in Clinica
Executive Summary
The FDA has granted streamlined review status to Fusion Medical Technologies' premarket approval application (PMA) to market its FloSeal surgical sealant in the US. The product, a collagen-derived matrix with thrombin, was submitted to the FDA in February and the agency is currently targeting final approval decisions for PMA applications to be completed in 180 days, said the Mountain View, California-based company. Fusion CE-marked the bioresorbable haemostatic sealant for use in a broad range of surgical procedures last month.