BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Carotid Sinus Nerve

    PMA: P180050 · Decision Aug 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Stimulator, Carotid Sinus Nerve
    Trade Name
    BAROSTIM NEO® System
    PMA Number
    P180050
    Device Class
    FDA Class 3
    Product Code
    DSR
    Generic Name
    Stimulator, carotid sinus nerve
    Regulation Number
    870.3850
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 16, 2019
    Date Received
    December 20, 2018
    Expedited Review
    N
    Docket Number
    19M-3862

    Advisory Committee Statement

    Approval for The BAROSTIM NEO System. The device is indicated for the improvement of symptoms of heart failure. quality of life, six-minute hall walk and functional status, for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction <= 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

    Classifications

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

    Product Code Device Name
    DSR Stimulator, Carotid Sinus Nerve