BEUDAMED
    Product Code: PNY FDA class 3

    Absorbable Coronary Drug-Eluting Stent

    Unknown

    The Absorbable Coronary Drug-Eluting Stent (product code PNY) is a Class 3 cardiovascular device consisting of an absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen; the drug coating is intended to inhibit restenosis. Class 3 classification requires Premarket Approval (PMA). The device is flagged as both an implant and a life-sustaining/life-supporting device, and no regulation number has been formally assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PNY
    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

    An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.