BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Leadless Cardiac Resynchronization Therapy (Crt)

    PMA: P240028 · Supplement: S001 · Decision Jun 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    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
    S001
    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
    June 18, 2025
    Date Received
    May 19, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    approval of the The WiSE-UP Registry (The WiSE System Utilization & Performance Registry) post-approval study protocol

    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)