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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S213 · Decision May 30, 2012
    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
    MODEL 74001 1X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION;MODEL 74002 2X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION
    PMA Number
    P840001
    Supplement Number
    S213
    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
    May 30, 2012
    Date Received
    April 30, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    TIGHTEN THE ACCEPTANCE CRITERIA FOR THE TITANIUM CONTENT OF THE UN-INSULATED WIRE AND QUALIFY AN ALTERNATE SUPPLIER OF THE ETHYLENE TETRA-FLUORO-ETHYLENE (ETFE) MICRO-EXTRUSION PROCESS.

    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