BEUDAMED
    Product Code: MFA FDA class 3

    Device, Removal, Pacemaker Electrode, Percutaneous

    Unknown

    The percutaneous pacemaker electrode removal device is a cardiovascular tool used to extract chronically implanted pacemaker or defibrillator leads from the heart and vasculature percutaneously, addressing complications such as lead infection, malfunction, or venous occlusion. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness given the high risk of the procedure. The product code is MFA and no regulation number or formal medical specialty has been assigned. The device is not an implant itself and does not sustain life.

    View on FDA
    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MFA
    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 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.