BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    PMA: P960009 · Supplement: S229 · Decision Nov 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
    Trade Name
    MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE
    PMA Number
    P960009
    Supplement Number
    S229
    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 17, 2015
    Date Received
    May 21, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION TO THE INDICATION FOR USE (IFU) FOR THE MEDTRONIC DEEP BRAIN STIMULATION (BDS) THERAPY FOR PARKINSON¿S DISEASE AND CORRESPONDING LABELING CHANGES ASSOCIATED WITH THE IFU MODIFICATION. BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN) USING MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE IS INDICATED FOR ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS IN INDIVIDUALS WITH LEVODOPA-RESPONSIVE PARKINSON'S DISEASE OF AT LEAST 4 YEARS¿ DURATION THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.

    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