BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P160003 · Decision Feb 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM
    PMA Number
    P160003
    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 14, 2017
    Date Received
    January 19, 2016
    Expedited Review
    N
    Docket Number
    16M-2652

    Advisory Committee Statement

    Approval for the PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients with de novo or restenotic lesions in native coronary arteries with a reference vessel diameter ranging from 2.25 mm to 4.0 mm and lesion length <= 31 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