BEUDAMED
    Product Code: OJX FDA class 3

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    Unknown

    The Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode is a drug-eluting implantable cardiac pacing lead used with compatible cardiac resynchronization therapy (CRT) devices to deliver pacing pulses to the left ventricle of the heart, with a drug-eluting coating intended to reduce local inflammation or tissue reaction at the electrode tip. Classified as FDA Class 3 requiring Premarket Approval (PMA) due to the significant risks of an implanted, life-sustaining cardiac device incorporating a drug component, reviewed by the Cardiovascular panel. The product code is OJX. It is flagged as both an implant and a life-sustaining/life-supporting device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    OJX
    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

    Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.

    FEI Numbers

    This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.