BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010012 · Supplement: S010 · Decision Jun 13, 2003
    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
    EASYTRAK LEAD MODELS IS-1 4535/4536/4537/4538 CORONARY VENOUS STEROID-ELUTING SINGLE-ELECTRODE PACE/SENSE LEAD
    PMA Number
    P010012
    Supplement Number
    S010
    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 13, 2003
    Date Received
    March 12, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGE FROM A LV-1 LEAD CONNECTOR TO AN IS-1 LEAD CONNECTOR DESIGN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EASYTRAK IS-1 LEAD, AND IS INDICATED FOR CHRONIC LEFT VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE.

    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)