BEUDAMED
    Product Code: LWR FDA class 3

    Heart-Valve, Non-Allograft Tissue

    Unknown

    The Non-Allograft Tissue Heart Valve (product code LWR) is a bioprosthetic heart valve constructed from animal tissue (xenograft), such as porcine or bovine pericardium, used to replace damaged or diseased native heart valves in patients requiring valve replacement surgery. It is classified as a Class 3 device requiring Premarket Approval (PMA), and is flagged as an implant given its surgical placement within the heart. The device is reviewed under the Cardiovascular (CV) panel and no regulation number has been formally assigned. It is not classified as life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    20
    Registration Numbers
    20
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LWR
    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 20 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.