BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060027 · Supplement: S024 · Decision Jun 28, 2010
    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
    OVATIO CRT-D AND PARADYM CRT-D
    PMA Number
    P060027
    Supplement Number
    S024
    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
    June 28, 2010
    Date Received
    May 17, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PROGRAMMER SOFTWARE VERSION SMARTVIEW 2.20UG1 FOR USE WITH THE OVATION AND PARADYM ICDS AND CRT-DS AND THE REPLY AND ESPRIT PACEMAKERS.

    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)