BEUDAMED
    Product Code: MOM FDA class 3

    System, Hemodynamic, Implantable

    Unknown

    The Implantable Hemodynamic System is a cardiovascular implant used to continuously monitor hemodynamic parameters such as pressure and flow within the heart or vasculature, enabling remote management of conditions like heart failure. Classified as FDA Class 3 due to its high-risk implantable nature, it requires Premarket Approval (PMA). The product code is MOM, reviewed by the Cardiovascular panel, and carries an implant flag.

    View on FDA
    510(k)s
    0
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MOM
    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 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.