BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P980049 · Supplement: S008 · Decision Feb 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD
    PMA Number
    P980049
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 14, 2003
    Date Received
    April 15, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DEFIBRILLATION LEAD PREVIOUSLY APPROVED FOR MANUFACTURE BY ANGEION UNDER THE TRADE NAME ANGEPASS. THE LEAD IS NOW BEING MANUFACTURED BY ELA MEDICAL, S.A. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SWIFT 1CT 4040 SERIES LEAD AND IS INDICATED FOR USE WITH AN ELA MEDICAL ICD IN PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: 1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA; 2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYARRHYTHMIA.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRM Defibrillator, Implantable, Dual-Chamber