BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S203 · Decision Oct 2, 2014
    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 AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS
    PMA Number
    P030017
    Supplement Number
    S203
    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
    October 2, 2014
    Date Received
    September 2, 2014
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LABELING CHANGE TO BE MADE TO THE PRECISION AND PRECISION SPECTRA MANUALS. THE REQUESTED CHANGE ADDS SUPPLEMENTAL INFORMATION TO THE ADVERSE EVENTS SECTION OF THE MANUALS IN ORDER TO PROVIDE ADDITIONAL DETAILS ON THE POSSIBILITY OF THE FORMATION OF REACTIVE TISSUE AROUND THE LEAD IN THE EPIDURAL SPACE WHICH MAY RESULT IN DELAYED ONSET OF SPINAL CORD COMPRESSION AND NEUROLOGICAL/SENSORY DEFICIT INCLUDING PARALYSIS.

    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