BEUDAMED
    Product Code: MRM FDA class 3

    Defibrillator, Implantable, Dual-Chamber

    Unknown

    The Dual-Chamber Implantable Defibrillator is a cardiovascular implant that combines defibrillation capability with dual-chamber pacing, detecting and treating both ventricular and atrial arrhythmias through sensing leads in both the right atrium and right ventricle. Classified as FDA Class 3 due to its high-risk, life-sustaining implantable nature, it requires Premarket Approval (PMA). The product code is MRM, and it carries both implant and life-sustaining support flags.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MRM
    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 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.