BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P150039 · Decision Feb 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    TRYTON SIDE BRANCH STENT
    PMA Number
    P150039
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 21, 2017
    Date Received
    October 30, 2015
    Expedited Review
    N
    Docket Number
    17M-1121

    Advisory Committee Statement

    Approval for the TRYTON Side Branch Stent. This device is indicated for improving the side branch luminal diameter of de novo native coronary artery bifurcation lesions (Medina Classification 1.1.1; 0.1.1; 1.0.1) with a side branch diameter stenosis of >=50% and a lesion length <=5.0 mm, along with reference vessel diameters >=2.5 mm to <=3.5 mm in the side branch and >=2.5 mm to <=4.0 mm in the main branch. The device is intended for use in conjunction with commercially available balloon expandable drug-eluting coronary stents in the main branch.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary