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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S361 · Decision May 12, 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
    S361
    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
    May 12, 2023
    Date Received
    May 4, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Remove the Verify Multi-lumen Tube Length step currently performed at the BSC Dorado manufacturing site during the assembly of the 15cm Precision M8 Adapter, Precision M8 Trial Adapter, and Vercise M8 Adapter of the Spinal Cord Stimulator (SCS) and Deep Brain Stimulation (DBS) systems.

    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