BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P920015 · Supplement: S091 · Decision Jul 2, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    SPRINT QUATTRO SINGLE COIL DF4, ACTIVE FIXATION LEAD
    PMA Number
    P920015
    Supplement Number
    S091
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 2, 2012
    Date Received
    May 23, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE CURRENTLY APPROVED MODEL 6935 SPRINTQUATTRO SECURE S LEAD WHICH IS A SINGLE DEFIBRILLATION COIL IS-1/DF-1 ACTIVE FIXATION LEAD FOR THE CREATION OF A NEW SPRINT QUATTRO SECURE S SINGLE DEFIBRILLATION COIL DF4 ACTIVE FIXATION LEAD, MODEL 6935M.

    Classifications

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

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)