BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030005 · Supplement: S237 · Decision Jun 4, 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
    VALITUDE™, VALITUDE X4, VISIONIST™, VISIONIST X4
    PMA Number
    P030005
    Supplement Number
    S237
    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
    June 4, 2024
    Date Received
    March 8, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    an update to the laser weld cover gas mixture and helium specification for Boston Scientific pacemaker and CRT-P pulse generators

    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)