BEUDAMED
    Product Code: PNJ FDA class 3 21 CFR 870.3610

    Leadless Pacemaker

    Cardiovascular

    The Leadless Pacemaker (product code PNJ) is a Class 3 cardiovascular device intended to treat bradycardia (slow heartbeats) by providing right atrial and/or right ventricular pacing therapy as necessary, regulated under 870.3610. Class 3 classification requires Premarket Approval (PMA). The device is flagged as both an implant and a life-sustaining/life-supporting device, reflecting the critical nature of cardiac pacing.

    View on FDA
    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PNJ
    Device Class
    FDA class 3
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

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

    Definition

    To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.