BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery, Drug-Eluting

    PMA: P100022 · Supplement: S022 · Decision May 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery, Drug-Eluting
    Trade Name
    Zilver PTX Drug-Eluting Peripheral Stent
    PMA Number
    P100022
    Supplement Number
    S022
    Device Class
    FDA Class 3
    Product Code
    NIU
    Generic Name
    Stent, superficial femoral artery, drug-eluting
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 2, 2017
    Date Received
    March 3, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the extension of the shelf life of the Zilver PTX Drug-Eluting Peripheral Stent to 24 months.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NIU Stent, Superficial Femoral Artery, Drug-Eluting