BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S058 · Decision Sep 14, 2012
    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
    EON MINI IPG NEUROSTIMULATION SYSTEM
    PMA Number
    P010032
    Supplement Number
    S058
    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
    September 14, 2012
    Date Received
    July 16, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODIFICATION TO THE MODEL 3721 EON MINI CHARGINGSYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL 3720 EON MINI LE CHARGER AND MODEL 3722 EON MINI LE CHARGING SYSTEM AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME, AND CHRONIC LOW BACK/LEG PAIN.

    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