BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Mitral Valve, Percutaneously Delivered

    PMA: P240042 · Supplement: S002 · Decision Oct 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prosthesis, Mitral Valve, Percutaneously Delivered
    Trade Name
    Tendyne™ Transcatheter Mitral Valve System
    PMA Number
    P240042
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    NPU
    Generic Name
    Prosthesis, mitral valve, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 4, 2025
    Date Received
    September 4, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study, "Registry-Based Real-World Use Surveillance," submitted to comply with the conditions of approval outlined in the approval order for P240042.

    Classifications

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

    Product Code Device Name
    NPU Prosthesis, Mitral Valve, Percutaneously Delivered