BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P890003 · Supplement: S054 · Decision Sep 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MODEL 8090 ANALYZER MODEL 5436 ANALYZER PATIENT CABLE, 5104/5104ANALYZER ADAPTORS, AND 8190 ANALYZER SOFTWARE
    PMA Number
    P890003
    Supplement Number
    S054
    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
    September 24, 1998
    Date Received
    April 3, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Medtronic "The Analyzer" Lead Analysis dEvice Model 8090 including the Model 5436 Analyzer Patient Cable, the Models 5103 and 5104 Analyzer Adaptors, and the Model 8190 Version 1.1 Software. "The Analyzer" is attached to the Medtronic Model 9790 Programmer (approved as P890003/S027) and the Model 8190 Software is installed onto the hard dirve of this Programmer. The device will be marketed under the trade name "Medtronic THE ANALYZER(TM) Lead Analysis Device Model 8090" and is indicated for use by a clinician to assess the pacing and sensing performance of the lead system during arrhythmia management device implantation or during invasive lead system troubleshooting.

    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