BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P960040 · Supplement: S032 · Decision Oct 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6
    PMA Number
    P960040
    Supplement Number
    S032
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 22, 2003
    Date Received
    April 1, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ENABLE THE AUTOMATIC INTRINSIC RHYTHM ID ALGORITHM UPDATE FEATURE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY VR/DR/VITALITY+ DR AICD SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2857 VERSION 1.6 AND IS INDICATED FOR USE AS FOLLOWS: THE VITALITY VR/DR/VITALITY+ DR AICE SYSTEM IS INDICATED FOR USE IN PATIENTS WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS. IN ADDITION, THIS DEVICE IS INDICATED FOR PROPHYLACTIC TREATMENT OF PATIENTS WITH A PRIOR MYOCARDIAL INFARCTION AND EF <30%.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)