BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S486 · Decision Jun 7, 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 S
    PMA Number
    P840001
    Supplement Number
    S486
    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
    June 7, 2021
    Date Received
    March 22, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change to Model 977D160 Vectris® 1x8 SC (Subcompact) Trial Screening Lead and Model 977D260 Vectris® 1x8 Compact Trial Screening Lead, to add an alternate material, 304 stainless-steel wire, for the braided shield of the Vectris lead body.

    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