BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P920015 · Supplement: S053 · Decision Apr 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    SPRINT QUATTRO, SPRINT QUATTRO SECURE MODELS 6947 AND 6935
    PMA Number
    P920015
    Supplement Number
    S053
    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
    April 28, 2009
    Date Received
    March 17, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW KIT CONTAINING INDIVIDUALLY PACKAGED LEAD ANCHORING SLEEVES. THE KIT WILL BE MARKETED UNDER THE TRADE NAME MODEL 5867 AS ANCHORING SLEEVE KIT AND IS INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE ENDOCARDIAL LEAD FAMILIES LISTED.

    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)