BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Carotid Sinus Nerve

    PMA: P180050 · Supplement: S009 · Decision Dec 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Stimulator, Carotid Sinus Nerve
    Trade Name
    Barostim System
    PMA Number
    P180050
    Supplement Number
    S009
    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
    December 22, 2023
    Date Received
    June 7, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the indications for use statement and inclusion of the post approval study (BeAT-HF) data into the labeling.

    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