BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Renal

    PMA: P890017 · Supplement: S007 · Decision Jan 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Stent, Renal
    Trade Name
    PALMAZ BALLOON EXPANDABLE STENTS
    PMA Number
    P890017
    Supplement Number
    S007
    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
    January 28, 2000
    Date Received
    July 16, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval is for additional models of the PALMAZ balloon expandable stent and the use of the OPTA LP and Powerflex Plus balloon catheters as delivery systems for the stents. The additional stent models include stents with an expansion range from 6 to 8 mm and lengths from 10 to 30 mm.

    Classifications

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

    Product Code Device Name
    NIN Stent, Renal