BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S488 · Decision Aug 12, 2021
    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, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
    PMA Number
    P840001
    Supplement Number
    S488
    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
    August 12, 2021
    Date Received
    May 17, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design change to the Recharger Therapy Manager (RTM) model 97755, to modify the interface between the antenna and the cable, to include an additional strain relief. This strain relief at the antenna-cable interface will include an elongated antenna section that is overmolded with a strain relief at the antenna-cable interface. Additionally, RTM cable length specification changes from 37 ± 1 inches to 35.4 ± 2 inches and the Crimp Ferrule minimum pull force strength will be increased from 3 lbs. minimum to 4.2 lbs.

    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