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

    Transcatheter Septal Occluder

    PMA: P050006 · Supplement: S113 · Decision Oct 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Transcatheter Septal Occluder
    Trade Name
    GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder
    PMA Number
    P050006
    Supplement Number
    S113
    Device Class
    FDA Class 3
    Product Code
    MLV
    Generic Name
    Transcatheter septal occluder
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 17, 2024
    Date Received
    September 19, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the use of new manufacturing equipment to be used by the supplier of the delivery catheter assemblies for the GORE® CARDIOFORM Septal Occluder (GSO Device) and GORE® CARDIOFORM ASD Occluder (GCA Device)

    Classifications

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

    Product Code Device Name
    MLV Transcatheter Septal Occluder