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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Coronary

    PMA: P110004 · Decision Apr 12, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    PRESILLION PLUS COCR CORONARY STENT RX SYSTEM
    PMA Number
    P110004
    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    Approved (Withdrawn)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
    April 12, 2012
    Date Received
    February 9, 2011
    Expedited Review
    N
    Docket Number
    12M-0407

    Advisory Committee Statement

    APPROVAL FOR THE PRESILLION PLUS COCR CORONARY STENT ON RX SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE ASSOCIATED WITH STENOTIC LESIONS IN DE NOVO NATIVE CORONARY ARTERIES (LENGTH <= 30 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM TO 4.00MM.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary