BEUDAMED
    Product Code: LEI FDA class 3

    Implant, Anti-Gastroesophageal Reflux

    Unknown

    An anti-gastroesophageal reflux implant is a surgically placed device designed to augment or restore the function of the lower esophageal sphincter, preventing acid reflux from the stomach into the esophagus in patients with chronic gastroesophageal reflux disease (GERD). It is classified as FDA Class 3, the highest risk category, requiring a Premarket Approval (PMA) application with full clinical safety and effectiveness data before marketing. The product code is LEI, with no regulation number or medical specialty formally assigned. This device is flagged as an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LEI
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    GU
    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 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.