CryoCor’s Cryoablation System For Atrial Flutter Is Non-Approvable, FDA Says
This article was originally published in The Gray Sheet
Executive Summary
CryoCor is planning to amend its PMA after receiving a non-approvable letter from FDA for its CryoCor cardiac cryoablation system for the treatment of atrial flutter, according to CEO Greg Ayers, MD
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CryoCor Ablation For Atrial Flutter Is Approvable With Conditions – Panel
CryoCor's cryoablation system is approvable for treatment of isthmus-dependent atrial flutter, FDA's Circulatory System Devices Panel concluded in an 8-2 vote June 27
CryoCor Ablation For Atrial Flutter Is Approvable With Conditions – Panel
CryoCor's cryoablation system is approvable for treatment of isthmus-dependent atrial flutter, FDA's Circulatory System Devices Panel concluded in an 8-2 vote June 27
Regulatory News In Brief
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)...