BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Decision Nov 21, 2001
    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 NEUROSTIMULATION (IPG) SYSTEMS
    PMA Number
    P010032
    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
    November 21, 2001
    Date Received
    May 29, 2001
    Expedited Review
    N
    Docket Number
    01M-0534

    Advisory Committee Statement

    APPROVAL FOR THE GENESIS NEUROSTIMULATION (IPG) SYSTEM. THE SYSTEM INCLUDES THE FOLLOWING COMPONENTS: THE MODEL 3608 PULSE GENERATOR, THE MODEL 3850 PATIENT PROGRAMMER, THE MODEL 1232 PROGRAMMING WAND AND THE MODEL 1210 PATIENT MAGNET. THE DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND 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