BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S527 · Decision Jan 8, 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
    Pain RC Spinal Cord Stimulation System (SCS) System
    PMA Number
    P840001
    Supplement Number
    S527
    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
    January 8, 2024
    Date Received
    August 29, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following: For P960009/S438, approval for: • Model B35300 Percept RC Implantable Neurostimulator (INS)• Model RS6230 Recharger Kit (including the WR9230 Recharger)• Model A610 Clinician Programmer Application (PPA) Software (Version 4.0) • Model A620 Patient Programmer Application (CPA) (Version 3.0) • A90300 Recharger Application Software (RAS) (Version 2.0) • Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept RC System.For H020007/S329, approval for: • Model B35300 Percept RC Implantable Neurostimulator (INS)• Model RS6230 Recharger Kit (including the WR9230 Recharger)• Model A610 Clinician Programmer Application (PPA) Software (Version 4.0) • Model A620 Patient Programmer Application (CPA) (Version 3.0) • A90300 Recharger Application Software (RAS) (Version 2.0) • Dystonia Kits (Models 33TH60, 33TH76, and 33TH69) • Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept RC System.For H050003/S289, approval for:• Model A610 Clinician Programmer Application (PPA) Software (Version 4.0) For P840001/S527, approval for: • Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept RC 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