BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

    PMA: P230035 · Decision Feb 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
    Trade Name
    AGENT Paclitaxel-Coated Balloon Catheter
    PMA Number
    P230035
    Device Class
    FDA Class 3
    Product Code
    OOB
    Generic Name
    Drug-eluting percutaneous transluminal coronary angioplasty catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 29, 2024
    Date Received
    October 5, 2023
    Expedited Review
    N
    Docket Number
    24M-1081

    Advisory Committee Statement

    The AGENT Paclitaxel-Coated Balloon Catheter is intended to be used after appropriate vessel preperation in adult patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.0 mm to 4.0 mm in diameter and lesions up to 26 mm in length for the purpose of improving myocardial perfusion when treating in-stent restenosis (ISR).

    Classifications

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

    Product Code Device Name
    OOB Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter