BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder

    PMA: P050006 · Supplement: S109 · Decision Apr 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Transcatheter Septal Occluder
    Trade Name
    GORE® CARDIOFORM ASD Occluder, GORE® CARDIOFORM Septal Occluder
    PMA Number
    P050006
    Supplement Number
    S109
    Device Class
    FDA Class 3
    Product Code
    MLV
    Generic Name
    Transcatheter septal occluder
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 29, 2024
    Date Received
    January 31, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change to the flush port tubing material that is a component of the Delivery Systems of the GORE® CARDIOFORM ASD Occluder and GORE® CARDIOFORM Septal Occluder

    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