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

    Transcatheter Septal Occluder

    PMA: P050006 · Supplement: S089 · Decision Jan 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Transcatheter Septal Occluder
    Trade Name
    GORE Cardioform Septal Occluder and GORE Cardioform ASD Occluder
    PMA Number
    P050006
    Supplement Number
    S089
    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
    January 26, 2021
    Date Received
    January 15, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Site changes to the LAL testing requirement and removal of cytotoxicity and infrared spectroscopy inspections for incoming components.

    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