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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Coronary

    PMA: P960010 · Decision Jun 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM
    PMA Number
    P960010
    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    Approved (Withdrawn)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
    June 27, 1997
    Date Received
    May 1, 1996
    Expedited Review
    N
    Docket Number
    98M-0726

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC WIKTOR(R) PRIME CORONARY STENT DELIVERY SYSTEM. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN NATIVE CORONARY ARTERIES AND BYPASS GRAFT VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 3.0 TO 4.5 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