BEUDAMED
    Product Code: LOZ FDA class 3

    Artificial Heart

    Unknown

    The Artificial Heart is a fully implantable mechanical device designed to replace or support the function of a failing natural heart, intended for patients with end-stage heart failure who are not candidates for transplant or as a bridge to transplantation. It is classified as a Class 3 (highest risk) device, the most stringent regulatory category, requiring Premarket Approval (PMA) from the FDA due to the critical life-supporting nature of this technology. The product code is LOZ; no specific regulation number is on file, and the medical specialty is not categorized in this record. This device carries the implant flag, indicating it is intended to be surgically placed inside the body.

    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
    LOZ
    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

    Definition

    P030011

    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.