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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S576 · Decision Nov 5, 2024
    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
    Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S
    PMA Number
    P840001
    Supplement Number
    S576
    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
    November 5, 2024
    Date Received
    October 10, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval of the use of a new termination paste that is used for the discoidal capacitor (a ceramic capacitor) which is used in the Restore sensor and Restore ultra products at Medtronic Energy and Component Center (Located in Brooklyn Center, MN)

    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