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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 Nerem St. 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
Predetermined Change Control Plan AuthorizedNo
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 S012 S013 S014 S015 S016 S010 S022 S004 S001 S002 
S006 S007 S005 S008 S017 S018 S019 S011 S020 S038 S039 S025 
S026 S042 S031 S045 S041 S035 S046 S056 S057 S058 S054 S055 
S067 S068 S078 S079 S075 S076 S082 S071 S084 S085 S086 S087 
S077 S029 S030 S023 S024 S028 S043 S032 S040 S036 S037 S044 
S033 S034 S048 S049 S061 S062 S064 S050 S051 S052 S053 S063 
S047 S065 S066 S059 S060 S072 S073 S074 S083 S080 S081 S070 
S069 S088 S089 S090 
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