BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030054 · Supplement: S046 · Decision Dec 14, 2006
    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
    CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM & EPIC HF
    PMA Number
    P030054
    Supplement Number
    S046
    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
    December 14, 2006
    Date Received
    November 30, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) AN ALTERNATE ELECTROLYTE (TM422) IN THE HIGH VOLTAGE CAPACITOR USED IN THE ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR AND EPIC II/II + DR/VR/HF DEVICES; AND 2) THE MINOR MODIFICATIONS TO THE CRYSTAL TUNING FORK USED IN EPIC, EPIC+, EPIC II/II +, ATLAS, ATLAS+, ATLAS II/II + DEVICES.

    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)