BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    PMA: P960009 · Supplement: S007 · Decision Jan 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
    Trade Name
    MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM
    PMA Number
    P960009
    Supplement Number
    S007
    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
    January 14, 2002
    Date Received
    September 30, 1999
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    02M-0217

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY WHICH INCLUDES THE MODEL 3387 DBS LEAD, MODEL 3389 DBS LEAD, MODEL 7482 EXTENSION, MODEL 7495 EXTENSION, MODEL 7426 SOLETRA NEUROSTIMULATOR, BURR HOLE RING AND CAP, MODEL 7432 PHYSICIAN PROGRAMMER, MODEL 7460 MEMORYMOD SOFTWARE CARTRIDGE, MODEL 7452 PATIENT MAGNET, MODEL 3625 TEST STIMULATOR, MODEL 3353/3354 LEAD FRAME KIT, AND ACCESSORIES. THE DEVICE IS INDICATED FOR BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN) AS AN ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED, LEVODOPA-RESPONSIVE PARKINSON'S DISEASE 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