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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
Generic Namesystem, hemodynamic, implantable
St. Jude Medical
387 technology circle nw
suite 500
atlanta, GA 30313
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
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), thecm1010 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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S008 S009 S010 S011