BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S331 · Decision Jan 24, 2020
    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
    Percision, Precision Spectra, Spectra WaveWriter; Precision Novi, Percision Montage and Percision Montage MRI Spinal Co
    PMA Number
    P030017
    Supplement Number
    S331
    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
    January 24, 2020
    Date Received
    October 28, 2019
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updating the Clinician Programmer (CP) computer to Surface Pro (SP6) with Windows 10 and for minor installation and labeling updates to the Bionic Navigator software used with the Precision, Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precision Montage MRI Spinal Cord Stimulator (SCS) 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