BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P910023 · Supplement: S080 · Decision Dec 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    ST.JUDE MEDICAL ICDS/CRT-D
    PMA Number
    P910023
    Supplement Number
    S080
    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
    December 16, 2005
    Date Received
    July 29, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ELIMINATION OF AN EXTRA LAYER OF PARYLENE COATING THAT IS APPLIED OVER THE HIGH VOLTAGE CAPACITOR PRIOR TO ITS INSTALLATION INTO THE DEVICE ASSEMBLY DURING THE ICD/CRT-D MANUFACTURING.

    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