BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S176 · Decision Nov 17, 2021
    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
    Proclaim SCS Neurostimulation System
    PMA Number
    P010032
    Supplement Number
    S176
    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
    November 17, 2021
    Date Received
    June 1, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for expanded magnetic resonance (MR) Conditional labeling for the Octrode 60cm Lead when implanted with the Proclaim XR IPGs (Models 3660 and 3662) and their associated accessories, including the port plug and lead anchors. This supplement requested expansion of the conditions of use within the MRI labeling to increase radiofrequency (RF) power limit from whole body SAR <=0.8 W/kg to normal operating mode (NOM) for scans using integrated body RF transmit coil with any receive coil, and also to expand implant locations eligible for MRI scans for lead tips in epidural space from T7 to T12 to C1 to S2.

    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