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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S315 · Decision Nov 12, 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
    RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATI
    PMA Number
    P840001
    Supplement Number
    S315
    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
    November 12, 2015
    Date Received
    October 13, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE UPDATE OF MANUFACTURING PROCESS CHANGES IN THE SURFACE TREATMENT OF METAL PIECE PART FOR THE IMPACTED IMPLATABLE PRODUCTS (I.E., TITANIUM, PLATINUM/IRIDIUM ALLOY, AND STAINLESS STEEL SUBCOMPONENTS) AS WELL AS MINOR UPDATES TO THE SURFACE TREATMENT SPECIFICATIONS FOR THESE SUBCOMPONENTS.

    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