BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P110004 · Supplement: S017 · Decision Jun 24, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    NIRXCELL COCR CORONARY STENT ON RX SYSTEM (NIRXCELL STENT SYSTEM)
    PMA Number
    P110004
    Supplement Number
    S017
    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
    June 24, 2016
    Date Received
    April 26, 2016
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol - OSB
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the following changes to the post-approval study for the device: revisions to the exclusion criteria and clarification of the serious adverse event definition.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary