BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910077 · Supplement: S072 · Decision Mar 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    LATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 6482
    PMA Number
    P910077
    Supplement Number
    S072
    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
    March 9, 2007
    Date Received
    February 8, 2007
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO THE LATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 6482 WHICH IS USED WITH THE PRIZM, VITALITY, CONTAK AND RENEWAL FAMILIES OF DEVICES. SPECIFICALLY, THE LABELING CHANGES INCLUDE THE INTRODUCTION OF ERRATA SHEETS TO ADDRESS THE FOLLOWING ISSUES: 1) YELLOW ALERT NOTIFICATION; 2) HEART RATE DISPLAY; AND 3) WEIGHT ALERT.

    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)