BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    PMA: P150031 · Supplement: S003 · Decision Apr 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
    Trade Name
    Vercise DBS System
    PMA Number
    P150031
    Supplement Number
    S003
    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
    April 24, 2018
    Date Received
    January 17, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for manufacturing sites located at Boston Scientific Limited, Cashel Road, Clonmel, Ireland (Vercise DBS IPG packaging, sterilization, and distribution operations); Guidant Puerto Rico B.V., No. 12, Road 698, Dorado, Puerto Rico (Vercise Leads, Extension, M8 Adaptor, and Physician’s Spare Kit manufacturing and sterilization operations); and Boston Scientific Corporation, 4100 Hamline Avenue North, St. Paul, Minnesota (Vercise external devices and surgical accessories manufacturing and sterilization operations).

    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