BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P980049 · Supplement: S024 · Decision Jan 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7
    PMA Number
    P980049
    Supplement Number
    S024
    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
    January 9, 2008
    Date Received
    October 16, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ISOLINE 2CT DEFIBRILLATION LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISOLINE 2CT5 & 2CT6 TRANSVENOUS DEFIBRILLATION LEADS AND IS INDICATED TO PROVIDE RIGHT VENTRICULAR PACING, SENSING AND DEFIBRILLATION WHEN USED AS PART OF AN ELA MEDICAL IMPLANTABLE DEFIBRILLATOR.

    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