BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S317 · Decision Aug 2, 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
    Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter
    PMA Number
    P030017
    Supplement Number
    S317
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 2, 2018
    Date Received
    July 3, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of Guidant Puerto Rico B.V. as an alternate qualified manufacturing site for the laser ablation of multi-lumen tubes used in the assembly of the following leads for the Precision®, Precision Spectra, Precision NoviTM, Precision Montage, Precision MontageTM MRI and Precision Spectra WaveWriter Spinal Cord Stimulator (SCS) Systems: Linear Leads, Linear ST Leads, Linear 3-4 Leads, Linear 3-6 Leads, Lead Extensions, M8 & S8 Adapters, Artisan Surgical Leads, Artisan MRI Surgical Leads, CovcrEdge Surgical Leads, CoverEdge X Surgical Leads, Infinion and lnfinion CX 16 Contact Leads.

    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