BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P880086 · Supplement: S101 · Decision Nov 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS
    PMA Number
    P880086
    Supplement Number
    S101
    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
    November 22, 2004
    Date Received
    August 30, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING: 1) A FIRMWARE MODIFICATION TO THE IDENTITY/IDENTITY ADX FAMILY OF PACEMAKERS TO CORRECT A POTENTIAL CONDITION THAT WOULD RESULT IN HARDWARE BACK-UP VVI PACING; AND 2) A COMPONENT DESIGN CHANGE TO IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILY OF PACEMAKERS MODIFYING THE PRINTED CIRCUIT BOARD USED TO CONNECT THE FEEDTHROUGH TO THE PACEMAKER CIRCUITRY.

    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