BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Leadless Cardiac Resynchronization Therapy (Crt)

    PMA: P240028 · Supplement: S003 · Decision Oct 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
    S003
    Device Class
    FDA Class 3
    Product Code
    SEG
    Generic Name
    Leadless Cardiac Resynchronization Therapy (CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 3, 2025
    Date Received
    September 10, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for an additional energy calibration inspection for the Transmitter subassembly

    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)