BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P210037 · Supplement: S011 · Decision Jun 25, 2025
    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
    Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
    PMA Number
    P210037
    Supplement Number
    S011
    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 25, 2025
    Date Received
    April 4, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for changes made to the Prospera SCS System embedded software (implant software [ISW]) and Neuro Service Center (NSC). Specifically, the Prospera SCS System embedded software (ISW) was updated to version 1.0.3, which included changes to the lead impedance measurements algorithm to provide more information during intraoperative testing and improve the accuracy of calculation of resistive measurements. The NSC was updated to version 1.6.3, which included changes to allow magnetic resonance imaging (MRI) mode entry if the automated lead impedance measurements are within range for the three most recent days and the consideration of touching leads condition as safe for MRI.

    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