BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P050023 · Supplement: S065 · Decision May 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    ILESTO,IFORIA,LUMAX
    PMA Number
    P050023
    Supplement Number
    S065
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 29, 2013
    Date Received
    April 29, 2013
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    A CHANGE IN STERILIZATION LOAD CONFIGURATION; 2) CHANGE IN STERILIZATION PRE-CONDITIONING; 3) STERILIZATION INJECTION PARAMETER CHANGES; AND 4) CHANGE TO THEPROCESS CHALLENGE DEVICE.

    Classifications

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

    Product Code Device Name
    MRM Defibrillator, Implantable, Dual-Chamber