BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

    PMA: P160039 · Supplement: S003 · Decision Sep 12, 2018
    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
    S003
    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
    September 12, 2018
    Date Received
    May 1, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change in the material of the remede IPG from Hysol to EPO-TEK 301 as the Epoxy Resin Encapsulation material.

    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