BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910077 · Supplement: S046 · Decision Feb 10, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM
    PMA Number
    P910077
    Supplement Number
    S046
    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
    February 10, 2005
    Date Received
    September 1, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM. THE MODEL 3120 PRM IS INTENDED TO BE USED AS A COMPLETE SYSTEM TO COMMUNICATE WITH GUIDANT IMPLANTABLE PULSE GENERATORS. THE SOFTWARE IN USE CONTROLS ALL COMMUNICATION FUNCTIONS FOR THE PULSE GENERATOR. FOR DETAILED SOFTWARE APPLICATION INSTRUCTIONS, REFER TO THE SYSTEM GUIDE FOR THE GUIDANT PULSE GENERATOR BEING INTERROGATED.

    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)