BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P890003 · Supplement: S068 · Decision Mar 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MEDTRONIC PACING LEADS
    PMA Number
    P890003
    Supplement Number
    S068
    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
    March 1, 2002
    Date Received
    October 15, 2001
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MEDTRONIC MODEL 72 DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH M DR) APPLICATION SOFTWARE, MODEL 9990 DESKTOP SOFTWARE, MODEL 9322 PATIENT MAGNET, AND MODEL 9767/9767L TELEMETRY PROGRAMMING HEAD (TELEMETRY B). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC M DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED 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
    DXY Implantable Pacemaker Pulse-Generator