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510(k) Data Aggregation

    K Number
    K031210
    Device Name
    MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
    Manufacturer
    METRONIC, INC.
    Date Cleared
    2003-05-16

    (29 days)

    Product Code
    DTB
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRONIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated.
    Device Description
    The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated. Two leads may be used for bipolar pacing. The lead features a platinized electrode that can be secured to the heart by gently pushing the barbed tip into the epicardium and securing it in myocardial tissue. Suture holes in the polyurethane base pad are provided for greater security. A polyester mesh allows for fibrous ingrowth for additional fixation. The lead also features an MP35N nickel alloy conductor, polyurethane insulation, and an IS-1 Unipolar (UNI) lead connector.
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