BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P900070 · Supplement: S031 · Decision Mar 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    META AND TEMPO PACEMAKERS
    PMA Number
    P900070
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 14, 2006
    Date Received
    February 22, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES. THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS. THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION. IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable