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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesystem, hemodynamic, implantable
PMA NumberP100045
Date Received12/15/2010
Decision Date05/28/2014
Product Code
MOM[ Registered Establishments with MOM ]
Docket Number 14M-0727
Notice Date 06/10/2014
Advisory Committee Cardiovascular
Clinical Trials NCT00531661
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the cardiomems hf system, which includes the cm2000 implantable pa sensor/monitor and transvenous catheter delivery system, the cm1000 patient electronics system (gsm), the cm1010 patient electronics system (gsm), and cm3000 hospital electronics system. This device is indicated for wirelessly measuring and monitoring pulmonary artery (pa) pressure and heart rate in new york heart association (nyha) class iii heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001