BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P960040 · Supplement: S025 · Decision Apr 23, 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
    PMA Number
    P960040
    Supplement Number
    S025
    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
    April 23, 2003
    Date Received
    November 14, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (VITALITY DR MODEL 1871, VITALITY VR MODEL 1870 AND VITALITY + DR MODEL 1872), AND MODEL 2857 SOFTWARE, VERSION 1.5. THE DEVICE IS INDICATED FOR USE IN THE FOLLOWING: THE VITALITY AICD SYSTEM IS INTENDED TO PROVIDE THERAPY FOR THE AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT AICD INCLUDE: 1) THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS, OR 2) PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION <= 30% (AS DEFINED IN THE MADIT II CLINICAL STUDY APPENDIX).

    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)