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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P060033 · Decision Feb 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
    PMA Number
    P060033
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    February 1, 2008
    Date Received
    November 20, 2006
    Expedited Review
    N
    Docket Number
    08M-0109

    Advisory Committee Statement

    APPROVAL FOR THE ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT ON THE OVER-THE-WIRE (OTW), RAPID EXCHANGE (RX), OR MULTI-EXCHANGE II (MX2) STENT DELIVERY SYSTEMS. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS OF LENGTH <= 27 MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSELL DIAMETERS OF >= 25 MM TO <= 3.5 MM.

    Classifications

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

    Product Code Device Name
    NIQ Coronary Drug-Eluting Stent