BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stent, Superficial Femoral Artery, Drug-Eluting

    PMA: P100022 · Supplement: S028 · Decision Aug 29, 2018
    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
    S028
    Device Class
    FDA Class 3
    Product Code
    NIU
    Generic Name
    Stent, superficial femoral artery, drug-eluting
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 29, 2018
    Date Received
    August 1, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of a delivery system component specification and changes to a supplier's extrusion line.

    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