BEUDAMED
    Product Code: MAE FDA class 3

    Occluder, Patent Ductus, Arteriosus

    Unknown

    The Patent Ductus Arteriosus Occluder (product code MAE) is a cardiovascular implant delivered via catheter to permanently close the patent ductus arteriosus, an abnormal opening between the aorta and pulmonary artery that normally closes after birth but may persist, causing cardiovascular complications. It is classified as a Class 3 device requiring Premarket Approval (PMA) and is flagged as an implant given its permanent deployment within the cardiovascular system. The device has no formal regulation number or medical specialty designation and is reviewed under the Cardiovascular (CV) panel. It is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MAE
    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 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.