BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    PMA: P150031 · Supplement: S065 · Decision Nov 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
    Trade Name
    Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System
    PMA Number
    P150031
    Supplement Number
    S065
    Device Class
    FDA Class 3
    Product Code
    NHL
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian symptoms
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 13, 2024
    Date Received
    September 29, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    which requested approval for the following:• Vercise Cartesia X Directional Lead Kits (Models DB-2203-30B and DB-2203-45B), • Vercise Cartesia HX 16-contact Directional Lead Kits (Models DB-2204-30B and DB-2204-45B), • 16-contact Lead Extension Kits (Models DB-3216-55 and DB-3216-95), • 2x8 Lead Extension Kits (Models DB-3128 and DB-3128-95), and • Vercise Physician’s Spare Kit (Model DB-2501).

    Classifications

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

    Product Code Device Name
    NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms