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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCardioMEMs HF System
Generic Namesystem, hemodynamic, implantable
ApplicantAbbott Medical
387 technology circle, nw
suite 500
atlanta, GA 30313
PMA NumberP100045
Supplement NumberS056
Date Received07/01/2021
Decision Date02/18/2022
Product Code MOM 
Docket Number 22M-0730
Notice Date 05/05/2022
Advisory Committee Cardiovascular
Clinical TrialsNCT03387813
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the CardioMEMS HF System. The device is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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