BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S323 · Decision May 14, 2019
    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 -Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage
    PMA Number
    P030017
    Supplement Number
    S323
    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
    May 14, 2019
    Date Received
    February 12, 2019
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to activate the on-board Bluetooth (BLE) functionality of your Freelink RC4 remote control device. The activation of the BLE is for data transmission from the Freelink RC4 to an application on a non-medical mobile device for the purpose of data logging.

    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