BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S122 · Decision Dec 8, 2008
    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
    RESTORE, RESTOREPRIME, RESTOREADVANCED, RESTORE PRIME ADVANCED, AND RESTOREULTRA NEUROSTIMULATION SYSTEMS
    PMA Number
    P840001
    Supplement Number
    S122
    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
    December 8, 2008
    Date Received
    October 8, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A STABILIZING COIL TO THE MODEL 37083 EXTENSION, A ¿POST-CURE¿ PROCESSING STEP AT THE DISTAL END OF THE MODELS 37083 AND 37082 EXTENSIONS, AND A PROXIMAL BOND STRENGTH (THERMAL BOND) DESIGN REQUIREMENT FOR MODELS 37083 AND 37082 EXTENSIONS.

    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