BEUDAMED
    Product Code: MIH FDA class 3

    System, Endovascular Graft, Aortic Aneurysm Treatment

    Unknown

    The Aortic Aneurysm Endovascular Graft System is a minimally invasive device delivered percutaneously via catheter to exclude an aortic aneurysm from systemic blood flow by lining the inside of the vessel with a graft, thereby preventing rupture. As a Class 3 implantable device, it requires Premarket Approval (PMA) due to the high risks associated with endovascular repair of life-threatening vascular conditions. It carries an implant flag, and no regulation number or specific medical specialty code is recorded in the classification database.

    View on FDA
    510(k)s
    0
    FEI Numbers
    34
    Registration Numbers
    34
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MIH
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.