BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    PMA: P130024 · Supplement: S010 · Decision Mar 10, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26

    Basic Information

    Device Name
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter
    Trade Name
    LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
    PMA Number
    P130024
    Supplement Number
    S010
    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
    March 10, 2016
    Date Received
    January 27, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to the addition of a new balloon folding process, implementation of a new in-process leak detection test, changes to the sampling plan for an in-process assay test, and labeling changes for sheath compatibility, crossing profile, and recommended balloon inflation time.

    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