BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

    PMA: P160039 · Supplement: S011 · Decision May 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
    Trade Name
    remede System
    PMA Number
    P160039
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    PSR
    Generic Name
    Implanted phrenic nerve stimulator for central sleep apnea
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 7, 2025
    Date Received
    February 6, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    revised MR Conditional labeling of the remed?® System to remove the requirement to program the IPG to OFF mode prior to MRI scanning as the device automatically enters and remains in the Therapy Disabled (Magnet Mode) state during MRI exposure

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PSR Implanted Phrenic Nerve Stimulator For Central Sleep Apnea