BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P980035 · Supplement: S014 · Decision Dec 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM
    PMA Number
    P980035
    Supplement Number
    S014
    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
    December 14, 2001
    Date Received
    October 24, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC KAPPA 900/800 PACEMAKER SERIES MODELS K(DR)901, K(DR)903, K(DR)906, K(DR)921, K(DR)931, K(DR)933, K(DR)801, K(DR)803, K(DR)806, K(D)901, K(D)903, K(D)906, KVDD901, KSR901, KSR903, AND KSR906 AND MODEL 9988 SOFTWARE SERIES 1.1. THE DEVICES ARE INDICATED FOR THE FOLLOWING: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY. 2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK; B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; AND E) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. 3) MEDTRONIC KAPPA 900/800 SERIES PACEMAKERS ARE ALSO INDICATED FOR DUAL CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY, WHICH INCLUDE: A) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; AND B) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM. 4) MEDTRONIC KAPPA 900/800 SERIES PACEMAKERS ARE ALSO INDICATED FOR VDD PACING IN PATIENTS HAVING ADEQUATE ATRIAL RATES AND THE FOLLOWING INDICATIONS: A) REQUIREMENTS FOR VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT. THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT OR WHEN PACEMAKER SYNDROME HAS EXISTED OR IS ANTICIPATED. B) NORMAL SINUS RHYTHM AND NORMAL AV CONDUCTION IN PATIENTS NEEDING VENTRICULAR PACING INTERMITTENTLY.

    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