Gamma System Late Thrombosis Concern Mitigated By Outside Data - Cordis
This article was originally published in The Gray Sheet
Executive Summary
Johnson & Johnson Cordis is hoping for a chance to make its case before FDA's Circulatory System Devices Panel that FDA should consider data neither generated by the company nor included in the premarket approval application for its Gamma brachytherapy system for treatment of coronary artery restenosis.