BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S211 · Decision Oct 8, 2024
    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 Neurostimulation System
    PMA Number
    P010032
    Supplement Number
    S211
    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 8, 2024
    Date Received
    February 22, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of an alternate ethylene oxide (EO) sterilization site, Centerpiece Sterilization Corporation Cycle ABB-059-R, located in Tijuana, Mexico, for the following products:1) Abbott Medical Spinal Cord Stimulation (SCS) Systems: • Family of Proclaim, Proclaim XR & Proclaim Plus IPGs; Protégé MRI™ & Protégé IPGs; Prodigy MRI™ & Prodigy IPGs; Eon Mini™ IPG; Eterna SCS IPG• Associated SCS leads, extensions and accessories 2) Abbott Medical Deep Brain Stimulation Systems• Family of Infinity DBS IPGs; Liberta DBS IPG• Associated DBS leads, extensions and accessories 3) Abbott Medical dorsal root ganglion stimulation system: • Proclaim DRG IPG• Associated DRG leads, extensions and accessories

    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