BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010031 · Supplement: S096 · Decision Jul 11, 2008
    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
    MEDTRONIC CONSULTA & MAXIMO ICDS
    PMA Number
    P010031
    Supplement Number
    S096
    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
    July 11, 2008
    Date Received
    April 10, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INC. 3 RAMWARE, WHICH CONTAINS A DESIGN CHANGE TO ADDRESS AN ISSUE WITH THE L409 INTEGRATED CIRCUIT (IC) IN THE CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, SECURA DR D224DRG AND SECURA VR D224VRC, MAXIMO II DR D284DRG AND MAXIMO II VR D284VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.

    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)