BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Programmer, Pacemaker

    PMA: P830045 · Supplement: S080 · Decision Dec 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Programmer, Pacemaker
    Trade Name
    ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
    PMA Number
    P830045
    Supplement Number
    S080
    Device Class
    FDA Class 3
    Product Code
    KRG
    Generic Name
    Programmer, pacemaker
    Regulation Number
    870.3700
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 21, 2001
    Date Received
    November 29, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ATLAS DR/VR (MODELS V-240 AND V-199) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTWARE VERSION 3.1. THESE DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION,FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.

    Classifications

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

    Product Code Device Name
    KRG Programmer, Pacemaker