BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P950029 · Supplement: S011 · Decision Oct 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    ELA RATE-RESPONSIVE PACEMAKERS
    PMA Number
    P950029
    Supplement Number
    S011
    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
    October 11, 2000
    Date Received
    August 18, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL IS FOR THE FOLLOWING MODIFICATIONS TO YOUR BRIO FAMILY OF PACEMAKERS: 1) MODIFY THE VALUE FOR THE NUMBER OF CYCLES THE DEVICE WILL ALLOW BEFORE A SELF TEST IS INITIATED WHEN THE SENSOR "CALLS FOR AN ELEVATED PACING RATE FOR A DURATION OR FREQUENCY THAT EXCEES REASONABLE PHYSIOLOGIC LIMITS" FROM 30,000 TO 100,000 CYCLES; AND2) CHANGING THE MINIMUM SENSING THRESHOLD DURING T-WAVE PROTECTION FROM 2.2 TO 2.5MV.

    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