BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P110004 · Supplement: S015 · Decision Aug 7, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    NIRXCELL COCR CORONARYSTENT ON RX SYSTEM
    PMA Number
    P110004
    Supplement Number
    S015
    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
    August 7, 2017
    Date Received
    December 11, 2015
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for labeling updates to the Instructions for Use (IFU) to reflect the long-term data from the Post-Approval BLAST Placebo Cohort study.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary