BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S169 · Decision Jun 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    IMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM
    PMA Number
    P960009
    Supplement Number
    S169
    Device Class
    FDA Class 3
    Product Code
    MHY
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian tremor
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 22, 2015
    Date Received
    March 18, 2013
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LABELING UPDATE THAT MODIFIES YOUR DEEP BRAIN STIMULATION (DBS) THERAPY INFORMATION FOR PRESCRIBER¿S AND THE DBS PATIENT THERAPY GUIDE. THE LABELING UPDATE IS TO MODIFY TWO PRECAUTIONS THAT APPEAR IN EACH MANUAL:1) REMOVE THE PRECAUTION ON POTENTIAL RELEASE OF NEUROTOXIC AND CARCINOGENIC COMPOUNDS FROM POLYURETHANE LEAD MATERIALS; AND2) MODIFY THE PRECAUTION ON LONG-TERM SAFETY OF MULTIPLE LEADS AND REPLACEMENT LEADS TO READ: THE LONG-TERM SAFETY ASSOCIATED WITH IMPLANTING MORE THAN ONE LEAD ON THE SAME SIDE OF THE BRAIN IS UNKNOWN.

    Classifications

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

    Product Code Device Name
    MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor