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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S375 · Decision Sep 22, 2017
    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
    Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead
    PMA Number
    P840001
    Supplement Number
    S375
    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
    September 22, 2017
    Date Received
    August 24, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Make a sub-tier supplier change to source a hypotube that will be coated with PTFE without the presence of PFOA as a manufacturing aid; 2) mask the flared portion of the hypotube during manufacturing to eliminate PTFE coating during forming operations; and 3) update the product specification to the correct referenced standard for EN 45502. i.e. The Change in particulate matter standard EN45502-1.

    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