BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S009 · Decision Jan 20, 2004
    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 (IPG) SYSTEM
    PMA Number
    P010032
    Supplement Number
    S009
    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
    January 20, 2004
    Date Received
    November 12, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF THE AXXESS PERCUTANEOUS LEAD MODELS 4143, 4146, 4153 AND 4156 WITH THE ANS GENESIS NEUROSTIMULATION (IPG) MODEL 3608, THE ANS GENESIS XP NEUROSTIMULATION (IPG) MODEL 3609, THE ANS GENESIS DUAL XP NEUROSTIMULATION (IPG) MODEL 3644 AND THE ANS GENESIS G4 NEUROSTIMULATION (IPG) MODEL 3604 WHICH ARE 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