BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010012 · Supplement: S395 · Decision Sep 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    COGNIS, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4, CRT-D
    PMA Number
    P010012
    Supplement Number
    S395
    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
    September 17, 2015
    Date Received
    July 13, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO PULSE GENERATOR FIRMWARE AND PROGRAMMER SOFTWARE, FOR LABELING CHANGES ASSOCIATED WITH THE SOFTWARE UPDATES, AND FOR THE COMBINATION OF PHYSICIAN TECHNICAL MANUALS AND DEVICE REFERENCE GUIDES INTO ONE COMPREHENSIVE DOCUMENT ACROSS DEVICE FAMILIES.

    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)