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510(k) Data Aggregation

    K Number
    K972242
    Device Name
    REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM
    Manufacturer
    MEDTRONIC VASCULAR
    Date Cleared
    1998-01-16

    (214 days)

    Product Code
    MXC
    Regulation Number
    870.2800
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    Matched: '870.3610'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic Model 9525 Reveal Insertable Loop Recorder is an implantable, patientactivated monitoring system that records subcutaneous ECG and is designed for diagnostic evaluation of patients who experience transient symptoms that may suggest a cardiac arrhythmia.
    Device Description
    The Reveal ILR system is designed to record and store subcutaneous electrocardiogram (ECG) during symptomatic events. The system consists of the Model 9525 implanted recorder and the Model 6190 Activator. A Medtronic Model 9790 programmer equipped with a Medtronic Model 9766A radio frequency telemetry head and Model 9802E software is required for programming and retrieving data from the recorder.
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    K Number
    K945627
    Device Name
    PIKOS LP 01, PIKOS LP E01
    Manufacturer
    BIOTRONIK, INC.
    Date Cleared
    1996-03-04

    (474 days)

    Product Code
    DXY
    Regulation Number
    870.3610
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    Matched: '870.3610'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pikos LP 01/LP B01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions: - · Sinus node arrest or bradycardia with or without AV conduction disorder. - · Intermittent or complete AV conduction block. - · Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia. - · Atrial fibrillation and ventricular bradyarrhythmia.
    Device Description
    The Pikos LP 01/LP B01 is a multi-programmable single chamber pulse generator which is designed and recommended for use with atrial or ventricular leads. The Pikos LP 01/LP E01 models offer a limited number of programmable options compared to those of the Pikos 01/E01 models.
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