BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Pulse-Generator, Pacemaker, External

    PMA: P920032 · Supplement: S008 · Decision Feb 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Pulse-Generator, Pacemaker, External
    Trade Name
    MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER
    PMA Number
    P920032
    Supplement Number
    S008
    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
    February 20, 2002
    Date Received
    August 16, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MICRO-PACE MODEL 4580. THE DEVICE IS INDICATED FOR "ANY CLINICAL SITUATION IN WHICH THE USE OF TEMPORARY PACEMAKER ON A PATIENT PROVIDES THERAPEUTIC OR DIAGNOSTIC VALUE, OR SERVES A PROPHYLACTIC PURPOSE. SPECIFICALLY, INDICATIONS FOR TEMPORARY PACEMAKERS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: INTERMITTENT OR COMPLETE HEART BLOCK ASSOCIATED WITH ASYSTOLE OR BRADYCARDIA, SYMPTOMATIC SINUS BRADYCARDIA, SURGICALLY-INDUCED HEART BLOCK AND HEART BLOCK ACCOMPANYING AN ACUTE MYOCARDIAL INFARCTION. ADDITIONALLY, TEMPORARY CARDIAC PACING HAS BEEN USED TO OVERDRIVE AND THEREBY TERMINATE ATRIAL ARRHYTHMIAS, INCLUDING ATRIAL FLUTTER. IT HAS BEEN USED IN PREPARATION FOR PERMANENT PACEMAKER IMPLANTATION TO ASCERTAIN THE THRESHOLDS FOR SENSING AND PACING ON THE ACUTE LEAD SYSTEM."

    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