BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Hemodynamic, Implantable

    PMA: P100045 · Decision May 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    System, Hemodynamic, Implantable
    Trade Name
    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
    PMA Number
    P100045
    Device Class
    FDA Class 3
    Product Code
    MOM
    Generic Name
    System, hemodynamic, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 28, 2014
    Date Received
    December 15, 2010
    Expedited Review
    Y
    Docket Number
    14M-0727

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MOM System, Hemodynamic, Implantable