BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Scaffold, Dissection Repair

    PMA: P190027 · Decision Apr 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Scaffold, Dissection Repair
    Trade Name
    Tack Endovascular System (4F, 1.5-4.5mm)
    PMA Number
    P190027
    Device Class
    FDA Class 3
    Product Code
    QCT
    Generic Name
    Scaffold, dissection repair
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 10, 2020
    Date Received
    October 1, 2019
    Expedited Review
    N
    Docket Number
    20M-1286

    Advisory Committee Statement

    Approval for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5 mm to 4.5 mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).

    Classifications

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

    Product Code Device Name
    QCT Scaffold, Dissection Repair