BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P050023 · Supplement: S074 · Decision May 4, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    ILESTO ICD'S AND CRT-D'S
    PMA Number
    P050023
    Supplement Number
    S074
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 4, 2014
    Date Received
    November 25, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MRI-CONDITIONAL LABELING FOR THE ENTOVIS SR / SR-T / DR / DR-T PACEMAKERS, AND THE SUPPORTING PROGRAMMER SOFTWARE VERSION PSW 1307.U. WHEN AN ENTOVIS PACEMAKER IS USED IN CONJUNCTION WITH SETROX S 53/60 OR SAFIO 53/60 PACEMAKER LEADS IT SHALL BEIDENTIFIED AS THE ENTOVIS PROMRI SYSTEM.

    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