BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S091 · Decision Feb 8, 2006
    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
    MEDTRONIC NEUROSTIMULATION SYSTEM (ITREL 3, RESTORE, SYNERGY, SYNERGY VERSITREL SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+
    PMA Number
    P840001
    Supplement Number
    S091
    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
    Approved
    Decision Code
    APPR
    Decision Date
    February 8, 2006
    Date Received
    January 20, 2006
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISED TEXT TO THE CAUTION IN THE "PLACING A PERCUTANEOUS LEAD" SECTION OF THE INSTRUCTIONS FOR USE SECTION OF THE FOLLOWING MANUALS: MODEL 3898 PISCES-OCTAD LEAD KIT IMPLANT MANUAL, MODEL 3487 A PISCES QUAD, MODEL 3887 PISCES QUAD COMPACT, AND MODEL 3888 PISCES QUAD PLUS LEAD KITS IMPLANT MANUAL, AND MODEL 3890 PISCES Z QUAD, MODEL 3891 PISCES Z QUAD COMPACT, AND MODEL 3892 PISCES Z QUAD PLUS LEAD KITS IMPLANT MANUAL.

    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