BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    PMA: P210025 · Decision Jun 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26

    Basic Information

    Device Name
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter
    Trade Name
    SurVeil Drug-Coated Balloon
    PMA Number
    P210025
    Device Class
    FDA Class 3
    Product Code
    ONU
    Generic Name
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 16, 2023
    Date Received
    June 21, 2021
    Expedited Review
    N
    Docket Number
    23M-3051

    Advisory Committee Statement

    Approval for the SurVeil DCB. The device is indicated for use for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (</= 180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 4 mm to 7 mm.

    Classifications

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

    Product Code Device Name
    ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter