BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Coronary

    PMA: P020040 · Decision Oct 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    NIRFLEX PREMOUNTED STENT
    PMA Number
    P020040
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    October 24, 2003
    Date Received
    September 25, 2002
    Expedited Review
    N
    Docket Number
    03M-0524

    Advisory Committee Statement

    APPROVAL FOR THE NIRFLEX PRE-MOUNTED CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO AND RESTENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER FROM 2.5 MM TO 4.0 MM.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary