BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Carotid Sinus Nerve

    PMA: P180050 · Supplement: S011 · Decision Apr 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Stimulator, Carotid Sinus Nerve
    Trade Name
    BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si
    PMA Number
    P180050
    Supplement Number
    S011
    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
    April 19, 2024
    Date Received
    November 9, 2023
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    labeling update to warnings and instructions regarding interaction with co-implants

    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