BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S072 · Decision Apr 15, 2004
    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
    ITRELL 3, SYNERGY AND SYNGERY VERSITREL SPINAL CORD STIMULATION SYSTEMS
    PMA Number
    P840001
    Supplement Number
    S072
    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
    April 15, 2004
    Date Received
    March 4, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO USE EALSTHANE RESINS AS ALTERNATE MATERIALS TO PELLETHANE RESINS IN LEADS, EXTENSIONS AND ACCESSORIES. THE FOLLOWING LEADS, EXTENSIONS AND ACCESSORIES WILL BE AFFECTED: MODEL 3487A - PISCES QUAD, MODEL 3887 - PISCES QUAD COMPACT, MODEL 3888 - PISCES QUAD PLUS, MODEL 3890 - PISCES Z QUAD, MODEL 3891 - PISCES Z QUAD COMPACT, MODEL 3892 - PISCES Z QUAD PLUS, MODEL 3898 - PISCES OCTAD, MODEL 3998 - SPECIFY, MODEL 3982A - SYMMIX, MODEL 3861 - TEMPORARY SCREENING LEAD, MODEL 3862 - VERIFY, MODEL 3587A - RESUME II, MODEL 3986A RESUMETL, MODEL 7471 EXTENSION, MODEL 7489 EXTENSION, MODEL 7495 EXTENSION, MODEL 7495LZ EXTENSION, MODEL 7496 EXTENSION, MODEL 7498 EXTENSION, MODEL 3550-09 - ACCESSORY KIT, MODEL 7441 - ACCESSORY KIT AND MODEL 7441NC - ACCESSORY KIT.

    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