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

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P040043 · Supplement: S124 · Decision Mar 25, 2021
    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 and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
    PMA Number
    P040043
    Supplement Number
    S124
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 25, 2021
    Date Received
    February 23, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    implementation of an FEP formulation change by a sub-tier supplier in the manufacturing of Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG Device), GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL SYSTEM (CMDS Device) and GORE® EXCLUDER® Iliac Branch Endoprosthesis Iliac Bifurcated Component (IBE IBC Device).

    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