BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S101 · Decision Oct 15, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55

    Basic Information

    Device Name
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
    Trade Name
    TRIPOLE, TRIPOLE 16C, TRIPOLE 16, LAMITRODE 4, LAMITRODE 44, LAMITRODE S-4, LAMITRODE S-8, LAMITRODE 88, LAMITRODE WINGE
    PMA Number
    P010032
    Supplement Number
    S101
    Device Class
    FDA Class 3
    Product Code
    LGW
    Generic Name
    Stimulator, spinal-cord, totally implanted for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 15, 2015
    Date Received
    September 15, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF A CHANGE TO THE TUMBLING PROCESS OF ELECTRODES USED ON THE SCS LEADS, EXTENSIONS, AND ADAPTERS.

    Classifications

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

    Product Code Device Name
    LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief