BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    PMA: P010031 · Supplement: S381 · Decision Apr 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26

    Basic Information

    Device Name
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
    Trade Name
    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES
    PMA Number
    P010031
    Supplement Number
    S381
    Device Class
    FDA Class 3
    Product Code
    NIK
    Generic Name
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 10, 2014
    Date Received
    May 29, 2013
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    Y
    Docket Number
    14M-0553

    Advisory Committee Statement

    APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE OF THE CRT-P AND CRT-D DEVICES TO INCLUDE NYHA FUNCTIONAL CLASS I, II, OR III PATIENTS WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION (LVEF) =< 50% ARE ON STABLE, OPTIMAL HEART FAILURE MEDICAL THERAPY IF INDICATED, AND HAVE ATRIOVENTRICULAR BLOCK (AV BLOCK) THAT IS EXPECTED TO REQUIRE A HIGH PERCENTAGE OF VENTRICULAR PACING THAT CANNOT BE MANAGED WITH ALGORITHMS TO MINIMIZE RIGHT VENTRICULAR PACING. THESE DEVICES ARE INDICATED FOR THE CONSULTA CRT-D MODEL D224TRK, CONCERTO II CRT-D MODEL D274TRK, CONSULTA CRT-D MODEL D204TRM, PROTECTA XT CRT-D MODEL D314TRM, PROTECTA CRT-D MODEL D334TRM, PROTECTA XT CRT-D MODEL D314TRG, PROTECTA CRT-D MODEL D334TRG, VIVA XT CRT-D MODEL DTBA1D4, VIVA XT CRT-D MODEL DTBA1D1, VIVA S CRT-D MODEL DTBB1D4, AND VIVA S CRT-D MODEL DTBB1D1: FOR ADDITIONAL INFORMATION PLEASE REFER TO THE APPROVAL ORDER.

    Classifications

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

    Product Code Device Name
    NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)