FDA to Review Cyberonic VNS Therapy System in June 2004

April 12, 2004

FDA to Review Cyberonic VNS Therapy System in June 2004

Cyberonics Inc. today announced that it has been formally notified by the Food and Drug Administration (FDA) that a meeting of FDA's Neurological Devices Advisory Panel has been scheduled for June 15, 2004 to review Cyberonics' PMA-Supplement seeking approval to market the VNS Therapy System. According to Cyberonics, VNS is being proposed "as an adjunctive long-term treatment of chronic or recurrent depression for patients over the age of 18 who are experiencing a major depressive episode that has not . . .