BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S090 · Decision Mar 4, 2015
    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
    GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM
    PMA Number
    P010032
    Supplement Number
    S090
    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
    March 4, 2015
    Date Received
    December 15, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DESIGN CHANGE TO THE STYLET MODELS THAT ARE USED WITHSJM SCS SYSTEMS; SPECIFICALLY, COATING THE STYLETS WITH A PFOA-FREE PTFE, RESULTING IN GENERATION 3 OF THE STYLETS. THIS SUPPLEMENT ALSO REQUESTED APPROVAL FOR A MANUFACTURING CHANGE TO TIGHTEN THE TOLERANCES ON THE TOOLING MANDREL USED TO MANUFACTURE THE ASSOCIATED LEAD MODELS.

    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