BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    PMA: P190019 · Supplement: S040 · Decision May 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter
    Trade Name
    Ranger™ Paclitaxel-Coated PTA Balloon Catheter
    PMA Number
    P190019
    Supplement Number
    S040
    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
    May 1, 2026
    Date Received
    November 24, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a manufacturing process change to the port weld for the Ranger Paclitaxel-Coated PTA Monorail 200cm catheter

    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