BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S271 · Decision Mar 13, 2017
    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
    SPECTRA WAVEWRITER SPINAL CORD STIMULATOR SYSTEM
    PMA Number
    P030017
    Supplement Number
    S271
    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
    March 13, 2017
    Date Received
    December 16, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for firmware/software updates to their Precision Spectra System Implantable Pulse Generator (IPG)/External Trial Stimulator (ETS), Freelink Remote Control (RC) and the Bionic Navigator (BN) Software. The Precision Spectra System will be rebranded under the name Spectra WaveWriter SCS System. The firmware/software has been updated to support new features. No changes were made to the hardware or material of any components in the existing system.

    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