BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Pulse-Generator, Pacemaker, External

    PMA: P920032 · Supplement: S006 · Decision Apr 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Pulse-Generator, Pacemaker, External
    Trade Name
    MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER
    PMA Number
    P920032
    Supplement Number
    S006
    Device Class
    FDA Class 2
    Product Code
    DTE
    Generic Name
    Pulse-generator, pacemaker, external
    Regulation Number
    870.3600
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 6, 2001
    Date Received
    January 18, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE TEMPORARY PACEMAKERS BY REPLACING THE ZENER DIODES USED FOR PROTECTING THE INTERNAL ELECTRONICS FROM HIGH VOLTAGE TRANSIENTS WITH A TRANSIENT VOLTAGE SUPPRESSOR.

    Classifications

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

    Product Code Device Name
    DTE Pulse-Generator, Pacemaker, External