BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030054 · Supplement: S049 · Decision Jul 25, 2007
    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
    QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS
    PMA Number
    P030054
    Supplement Number
    S049
    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 25, 2007
    Date Received
    February 5, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DISTAL TIP MODIFICATIONS TO THE QUICKSITE LEAD FAMILY TO REDUCE THE LENGTH OF RIGID SECTIONS AND INCREASE LEAD FLEXIBILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS. QUICKFLEX LEADS ARE 6 FRENCH, TRANSVENOUS, STEROID ELUTING, BIPOLAR, IS-1 COMPATIBLE, S-SHAPED CURVE, PASSIVE FIXATION LEADS INTENDED FOR PERMANENT SENSING AND PACING OF THE LEFT VENTRICLE WHEN USED WITH A COMPATIBLE ST. JUDE MEDICAL?S BIVENTRICULAR SYSTEM.

    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)