BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010031 · Supplement: S141 · Decision Mar 11, 2009
    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
    CONSULTA CRT-D, CONCERTO II CRT-D AND MAXIMO II CRT-D
    PMA Number
    P010031
    Supplement Number
    S141
    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
    March 11, 2009
    Date Received
    January 16, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MINOR DESIGN CHANGES:1) TWO (2) IC DESIGN CHANGES¿ L310 AND L3542) TWO (2) ALTERNATE COMPONENTS¿ DIODE CHANGE (CURRENTLY: XD423 AND PROPOSED: XD445)¿ INSULATED-GATE BIPOLAR TRANSISTOR (IGBT) CHANGE (CURRENTLY: XD405 ANDPROPOSED: XD447)3) PRINTED WIRE BOARD (PWB) CHANGES TO ACCOMMODATE THE ALTERNATE (XD445 DIODE ANDXD447 IGBT) COMPONENTS AND MANUFACTURABILITY IMPROVEMENTS.4) FOUR (4) ICS (L303, L310, L354, AND L409) TO BE TRANSFERRED TO AN ALTERNATIVE ICFABRICATION VENDOR.

    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)