BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P920015 · Supplement: S039 · Decision Apr 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935
    PMA Number
    P920015
    Supplement Number
    S039
    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 29, 2008
    Date Received
    March 3, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SINGLE-DEFIBRILLATION-COIL VERSION OF THE FDA APPROVED SPRINT QUATTRO MODEL 6947 DUAL-DEFIBRILLATION ?COIL ACTIVE-FIXATION RIGHT VENTRICULAR LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER TE TRADE NAME SPRINT QUATTRO MODEL 6935 LEAD AND IS INTENDED FOR LONG-TERM USE IN THE RIGHT VENTRICLE FOR PATIENTS INDICATED FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.

    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)