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

    Mitral Valve Repair Devices

    PMA: P100009 · Supplement: S083 · Decision Mar 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Mitral Valve Repair Devices
    Trade Name
    MitraClip NTR/XTR Clip Delivery System; MitraClip G4 System
    PMA Number
    P100009
    Supplement Number
    S083
    Device Class
    FDA Class 3
    Product Code
    NKM
    Generic Name
    Mitral valve repair devices
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 6, 2026
    Date Received
    February 6, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    harmonization across preconditioning parameters in preconditioning cells at one sterilization facility, and implementation of sustainable reduced ethylene oxide sterilization cycles at two other sterilization facilities

    Classifications

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

    Product Code Device Name
    NKM Mitral Valve Repair Devices