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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
Generic NameSystem, hemodynamic, implantable
ApplicantAbbott Medical
387 Technology Circle, NW
Suite 500
Atlanta, GA 30313
PMA NumberP100045
Date Received12/15/2010
Decision Date05/28/2014
Product Code MOM 
Docket Number 14M-0727
Notice Date 06/10/2014
Advisory Committee Cardiovascular
Clinical TrialsNCT00531661
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S009 S010 S017 S018 S019 S004 S001 S002 S006 S007 S005 
S011 S012 S008 S022 S013 S014 S015 S016 S029 S030 S020 S038 
S039 S040 S041 S044 S042 S033 S034 S058 S056 S057 S051 S052 
S053 S061 S062 S067 S068 S024 S031 S028 S025 S026 S023 S036 
S037 S043 S035 S032 S045 S064 S070 S065 S066 S046 S047 S054 
S055 S048 S049 S050 S063 S059 S060 S071 S072 S069 S074 
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