BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Carotid Sinus Nerve

    PMA: P180050 · Supplement: S013 · Decision Jan 30, 2025
    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
    Supplement Number
    S013
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 30, 2025
    Date Received
    January 10, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a manufacturing change from electrode staking to laser welding for the Carotid Sinus Lead

    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