BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    PMA: P030005 · Supplement: S238 · Decision Jul 18, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25

    Basic Information

    Device Name
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
    Trade Name
    Latitude™ NXT Patient Management System (INVIVE, INTUA, VISIONIST, VALITUDE)
    PMA Number
    P030005
    Supplement Number
    S238
    Device Class
    FDA Class 3
    Product Code
    NKE
    Generic Name
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 18, 2024
    Date Received
    April 19, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    server and communicator software updates for the LATITUDE NXT System including both LATITUDE Wave Communicator model 6290 and LATITUDE NXT Server Software model 6460.

    Classifications

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

    Product Code Device Name
    NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)