BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P880086 · Supplement: S103 · Decision Apr 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,
    PMA Number
    P880086
    Supplement Number
    S103
    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
    April 6, 2005
    Date Received
    February 22, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PRE-MOLDED HEADER DESIGN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380, IDENTITY ADX VDR MODEL 5480, AND INTEGRITY ADX DR MODEL 5360.

    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