BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P920015 · Supplement: S017 · Decision Dec 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    SPRINT QUATTRO MODEL 6944 LEAD
    PMA Number
    P920015
    Supplement Number
    S017
    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
    December 15, 2000
    Date Received
    June 20, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC(R) SPRINT(TM) QUATTRO(TM) MODEL 6944 LEAD WHICH IS INTENDED FOR SINGLE LONG-TERM USE IN THE RIGHT VENTRICLE. THIS LEAD HAS APPLICATION FOR PATIENTS IN WHICH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS ARE INDICATED.

    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)