BEUDAMED
    Product Code: MMY FDA class 3

    Lipoprotein, Low Density, Removal

    Unknown

    The Low Density Lipoprotein (LDL) Removal device is an extracorporeal system used in lipid apheresis to selectively remove low-density lipoprotein cholesterol from a patient's blood, used in the treatment of severe familial hypercholesterolemia in patients who cannot achieve adequate LDL reduction through diet and drug therapy alone. As a Class 3 device, it requires Premarket Approval (PMA) given the high risks associated with extracorporeal blood processing. No regulation number or medical specialty code is recorded, and it carries no implant or life-sustaining flags.

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    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MMY
    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 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.