BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P980049 · Supplement: S021 · Decision Jan 15, 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
    PMA Number
    P980049
    Supplement Number
    S021
    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 15, 2008
    Date Received
    May 16, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) MODIFICATIONS TO THE SWIFT 1CT SERIES ICD LEAD TO CREATE A DUAL-COIL, INTEGRATED BIPOLAR, ACTIVE-FIXATION ICD LEAD. THE NEW LEAD WILL BE MARKETED UNDER THE NAME ISOLINE 2CR AND IS INDICATED FOR USE WITH ELA MEDICAL IMPLANTABLE DEFIBRILLATORS; 2) MANUFACTURING SITE AT SORIN BIOMEDICA CRM SRL, SALUGGIA, ITALY AND TWO STERILIZATION SITES AT BIOSTER SPA, BERGAMO, ITALY.

    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