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

    Leadless Cardiac Resynchronization Therapy (Crt)

    PMA: P240028 · Supplement: S002 · Decision Sep 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Leadless Cardiac Resynchronization Therapy (Crt)
    Trade Name
    WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
    PMA Number
    P240028
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    SEG
    Generic Name
    Leadless Cardiac Resynchronization Therapy (CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 3, 2025
    Date Received
    August 6, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    additional wire bonder equipment

    Classifications

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

    Product Code Device Name
    SEG Leadless Cardiac Resynchronization Therapy (Crt)