BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P880086 · Supplement: S096 · Decision Oct 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE
    PMA Number
    P880086
    Supplement Number
    S096
    Device Class
    FDA Class 3
    Product Code
    DXY
    Generic Name
    implantable pacemaker Pulse-generator
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 17, 2003
    Date Received
    September 11, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE EPIC+ ICDS TO INCLUDE HIGHER ENERGY OUTPUT, SOFTWARE MODIFICATIONS, AND A DIFFERENT HEADER TYPE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODELS V-242, V-243, V-193 AND V-193C, EPIC+ MODELS V-233, V-239 AND V196, AND MODEL 3307 V.4.5A SOFTWARE, AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATIONS

    Classifications

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

    Product Code Device Name
    DXY Implantable Pacemaker Pulse-Generator