BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010015 · Supplement: S048 · Decision Nov 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    INSYNC & INSYNC III CRT-P
    PMA Number
    P010015
    Supplement Number
    S048
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 21, 2008
    Date Received
    July 28, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE. UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)