Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Ablation panel: CryoCor's cryoablation catheter system PMA for atrial flutter will go before FDA's Circulatory System Devices Panel June 27, the agency announced May 9. The company filed an amendment to its original application in November 2006, following a February 2006 non-approvable letter from FDA (1"The Gray Sheet" Feb. 27, 2006, p. 15)...