BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

    PMA: P230035 · Supplement: S002 · Decision Jun 28, 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
    Supplement Number
    S002
    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
    June 28, 2024
    Date Received
    May 31, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230035

    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