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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S364 · Decision Jun 30, 2023
    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
    Precision Spinal Cord Stimulator (SCS) Systems
    PMA Number
    P030017
    Supplement Number
    S364
    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
    June 30, 2023
    Date Received
    June 2, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    New manufacturing site for current supplier Meier Tool & Engineering, Inc. (Meier). Meier manufactures the tacked back-up band, Bluetooth antenna, positive and negative battery contacts, and Printed Circuit Board (PCB) metal spacer components for Boston Scientific Neuromodulation Corporation (BSN) Implantable Pulse Generators (IPGs) and External Trial Stimulators (ETS). These parts are non-patient-contacting components used within the Spinal Cord Stimulator (SCS) and Deep Brain Stimulation (DBS). Meiers proposed facility move to Brooklyn Park, MN was approved for the Paddle Lead Disc Electrodes and Slotted Paddle Disc Electrodes used in SCS Leads.

    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