BEUDAMED
    Product Code: PRL FDA class 3

    Iliac Covered Stent, Arterial

    Unknown

    The Iliac Covered Stent, Arterial is an implantable endovascular device used to treat de novo or restenotic lesions in iliac arteries, providing a covered stent structure that excludes diseased arterial segments and maintains vessel patency. It is classified as FDA Class 3, requiring Premarket Approval (PMA) due to the high-risk nature of implantable vascular devices in a critical arterial location. Product code PRL; flagged as an implant; no regulation number assigned; not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PRL
    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

    For the treatment of de novo or restenotic lesions found in iliac arteries

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.