BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Renal

    PMA: P060006 · Supplement: S064 · Decision Aug 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Stent, Renal
    Trade Name
    EXPRESS SD RENAL MONORAIL PREMOUNTED SYSTEM
    PMA Number
    P060006
    Supplement Number
    S064
    Device Class
    FDA Class 3
    Product Code
    NIN
    Generic Name
    STENT, RENAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 12, 2015
    Date Received
    November 14, 2014
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REMOVAL OF THE STENT MASS IN-PROCESS MEASUREMENT AND AN ALTERNATE SAMPLING PLAN FOR THE WALL THICKNESS IN-PROCESS MEASUREMENT.

    Classifications

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

    Product Code Device Name
    NIN Stent, Renal