BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P030005 · Supplement: S249 · Decision Oct 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
    Trade Name
    U125 VALITUDE™ CRT-P,U128 VALITUDE™ X4 CRT-P,U225 VISIONIST™ CRT-P,U226 VISIONIST™ CRT-P,U228 VISIONIST™ X4 CRT-P
    PMA Number
    P030005
    Supplement Number
    S249
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 22, 2025
    Date Received
    September 30, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to extend the time that solder paste can remain on the stencil before cleaning when building pulse generator printed circuit board assemblies

    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)