BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Carotid Sinus Nerve

    PMA: P180050 · Supplement: S014 · Decision May 23, 2025
    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
    S014
    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
    May 23, 2025
    Date Received
    February 25, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for removal of the implant adapter component and minor instructions for use updates

    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