BEUDAMED
    Product Code: MPC FDA class 3 21 CFR 870.5300

    Atrial Defibrillator

    Cardiovascular

    The Atrial Defibrillator is an implantable cardiovascular device used to detect and terminate atrial tachyarrhythmias, such as atrial fibrillation, by delivering electrical shocks to restore normal heart rhythm. It is intended for patients who have indications for an ICD and who have or are at risk of developing atrial tachyarrhythmias. Classified as FDA Class 3 under 21 CFR 870.5300, it requires Premarket Approval (PMA). The product code is MPC, and it carries both implant and life-sustaining support flags.

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    Basic Information

    Product Code
    MPC
    Device Class
    FDA class 3
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    Definition

    Call for PMAs 12/26/96 (61 FR 50706 9/27/96)) Patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias.