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

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

    PMA: P030005 · Supplement: S254 · Decision Jun 3, 2026
    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
    VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4
    PMA Number
    P030005
    Supplement Number
    S254
    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
    June 3, 2026
    Date Received
    May 4, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to implement a new process monitor for feedthrough sputter thickness and add the associated design output specification for pulse generator devices

    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)