Testimony to the FDA’s Circulatory System Devices Panel on the Premarket Approval (PMA) Application for the CardioMEMS Champion HF Monitoring System
October 9, 2013
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Public Citizen urges the Food and Drug Administration to not approve the CardioMEMS System for monitoring heart failure patients. There is insufficient evidence that the device is effective or that the benefits of its use outweigh the risks related to its implantation.