BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

    PMA: P160039 · Supplement: S006 · Decision Jul 28, 2021
    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
    S006
    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
    July 28, 2021
    Date Received
    January 19, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for reducing the IPG size, increasing the IPG battery longevity, reducing the number of set screw connections between the lead terminal and IPG header, and improving features within the Remede Programer software application and the remede Reports application.

    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