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Given our current clinical knowledge and experience over the past several years, FDA is planning to revise this guidance. Please contact Elias Malis, Chief, Cardiac Electrophysiology and Monitoring Branch at 240 276-4080 or at elias.mallis@fda.hhs.gov, if you have comments or questions about the design of clinical studies for ventricular tachycardia ablation.

Updated September 26, 2006

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