BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S141 · Decision Jul 19, 2018
    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
    Spinal Cord Stimulation (SCS) External Programmer Apps
    PMA Number
    P010032
    Supplement Number
    S141
    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
    July 19, 2018
    Date Received
    February 13, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for:1) P140009/S037: MR Conditional labeling, Firmware version 1.3, and Clinician Programmer and Patient Controller Apps version 3.7 (DBS MRI mode, DBS shared frequency mode, DBS Multistim Programming, DBS Monopolar Survey Mode, and minor software changes); and2) P010032/S141 and P150004/S20: Firmware version 1.3 and Clinician Programmer and Patient Controller Apps version 3.7 (minor software changes).

    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