BEUDAMED
    Product Code: SEG FDA class 3

    Leadless Cardiac Resynchronization Therapy (Crt)

    Unknown

    Leadless cardiac resynchronization therapy (CRT) is a Class III implantable device (PMA required) intended to deliver cardiac resynchronization therapy using a leadless left ventricular implant, eliminating the need for transvenous leads in patients with heart failure requiring CRT. As a Class III device, it requires Premarket Approval, reflecting its high-risk nature as a novel cardiac implant technology. The product code is SEG, reviewed by the Cardiovascular panel; the device is flagged as an implant but is not designated as life-sustaining in this classification record.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    SEG
    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

    Leadless Cardiac Resynchronization Therapy (CRT) is intended to deliver CRT using a leadless left ventricular implant

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.