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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Coronary

    PMA: P160014 · Decision Feb 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    COBRA PzF NanoCoated Coronary Stent System
    PMA Number
    P160014
    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    Approved (Withdrawn)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
    February 21, 2017
    Date Received
    May 2, 2016
    Expedited Review
    N
    Docket Number
    17M-1122

    Advisory Committee Statement

    Approval for the COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to do novo lesions in native coronary arteries. The COBRA PzF Stent System is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.5-4.0 mm and lesion length of <24 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