J&J/Cordis Trufill Embolic Agent PMA Gains Panel Okay For Brain AVMs
This article was originally published in The Gray Sheet
Executive Summary
Approval of Cordis' Trufill liquid embolic agent should be conditioned on the company's completion of studies requested by FDA in an earlier deficiency letter on the firm's premarket approval application, the agency's Neurological Devices Advisory Panel agreed at its May 11 meeting in Gaithersburg, Maryland.