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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P190020 · Decision Apr 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    BioFreedom Drug Coated Coronary Stent System
    PMA Number
    P190020
    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    Approved (Withdrawn)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
    April 14, 2022
    Date Received
    August 16, 2019
    Expedited Review
    N
    Docket Number
    22M-0601

    Advisory Committee Statement

    Approval for the BioFreedom Drug Coated Stent System. This device is indicated for improving coronary luminal diameter in patients at high risk for bleeding with symptomatic ischemic heart disease due to de novo lesions of length <= 32 mm in native coronary arteries with a reference diameter ranging between 2.25 mm and 4.0 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