BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Renal

    PMA: P060006 · Supplement: S043 · Decision Jun 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Stent, Renal
    Trade Name
    EXPRESS SD RENAL PREMOUNTED STENT SYSTEM
    PMA Number
    P060006
    Supplement Number
    S043
    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
    June 21, 2013
    Date Received
    March 29, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.

    Classifications

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

    Product Code Device Name
    NIN Stent, Renal