BEUDAMED
    Product Code: NPU FDA class 3

    Prosthesis, Mitral Valve, Percutaneously Delivered

    Unknown

    The percutaneously delivered mitral valve prosthesis is a cardiovascular implant intended to replace a patient's diseased mitral heart valve using a catheter-based percutaneous approach, avoiding open-chest surgery. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA). Product code NPU carries both implant and life-sustaining flags and is reviewed by the Cardiovascular panel.

    View on FDA
    510(k)s
    0
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NPU
    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

    These devices are intended to replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.