BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mitral Valve Repair Devices

    PMA: P100009 · Supplement: S055 · Decision Nov 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Mitral Valve Repair Devices
    Trade Name
    MitraClip™ G4 Clip Delivery System
    PMA Number
    P100009
    Supplement Number
    S055
    Device Class
    FDA Class 3
    Product Code
    NKM
    Generic Name
    Mitral valve repair devices
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 20, 2023
    Date Received
    May 24, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for various updates to the Instructions for Use: (1) to add the final clinical results of Post-Approval Study #1, Continued Follow-up of the COAPT Trial Pivotal Cohort, ordered in our March 14, 2019, letter; (2) to remove the Anatomic Considerations section; and (3) to add the results of the postmarket EXPAND and EXPAND G4 studies.

    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