BEUDAMED
    Product Code: QFV FDA class 3

    Implantable Pulse Generator

    Unknown

    The Implantable Pulse Generator is a cardiovascular implantable device designed to deliver Cardiac Contractility Modulation (CCM) signals during the absolute refractory period of the cardiac cycle to improve cardiac function in patients with heart failure. It is classified as FDA Class 3, requiring Premarket Approval (PMA) due to the high risks of cardiac implantation and its life-sustaining function. The product code is QFV with no assigned regulation number, reviewed by the Cardiovascular panel. This device carries both an implant flag and a life-sustaining/life-supporting flag.

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

    Basic Information

    Product Code
    QFV
    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

    Deliver Cardiac Contractility Modulation signals during the absolute refractory period

    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.