BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P040043 · Supplement: S040 · Decision Jan 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    GORE TAG THORACIC ENDOPROSTHESIS
    PMA Number
    P040043
    Supplement Number
    S040
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 13, 2012
    Date Received
    July 1, 2011
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    12M-0056

    Advisory Committee Statement

    APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THE DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ISOLATED LESIONS (NOT INCLUDING DISSECTIONS) OF THE DESCENDING THORACIC AORTA, IN PATIENTS WHO HAVE APPROPRIATE ANATOMY INCLUDING ADEQUATE ILIAC/FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM, AND >= 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION.

    Classifications

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

    Product Code Device Name
    MIH System, Endovascular Graft, Aortic Aneurysm Treatment