BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery, Drug-Eluting

    PMA: P100022 · Supplement: S038 · Decision Nov 2, 2021
    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
    S038
    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
    November 2, 2021
    Date Received
    August 11, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of the US ZILVER PTX POST-APPROVAL STUDY 2 (PAS 2) results to the Instructions for Use

    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