BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Renal

    PMA: P100028 · Supplement: S003 · Decision Mar 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Stent, Renal
    Trade Name
    FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
    PMA Number
    P100028
    Supplement Number
    S003
    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
    March 28, 2014
    Date Received
    January 28, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL DELIVERY SYSTEM (FORMULA 535 DELIVERY SYSTEM) FOR THE FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM.

    Classifications

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

    Product Code Device Name
    NIN Stent, Renal