BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Renal

    PMA: P890017 · Supplement: S010 · Decision Jul 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Stent, Renal
    Trade Name
    PALMAZ BALLOON-EXPANDABLE STENT
    PMA Number
    P890017
    Supplement Number
    S010
    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
    July 10, 2002
    Date Received
    December 6, 2001
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    02M-0348

    Advisory Committee Statement

    APPROVAL FOR THE CORDIS PALMAZ BALLOON EXPANDABLE STENT (MODELS P104R, P154R, P204R). THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES FOLLOWING SUBOPTIMAL PERCUTANEOUS RENAL ANGIOPLASTY (PTRA) OF A DE NOVO OR RESTENOTIC LESION (<=22 MM IN LENGTH) LOCATED WITHIN 10 MM OF THE AORTORENAL ARTERY BORDER AND WITH A REFERENCE VESSEL DIAMETER OF >= 4 MM AND <= 8 MM. SUBOPTIMAL PTRA RESULTS ARE DEFINED BY ONE OR MORE OF THE FOLLOWING UNFAVORABLE RESULTS: >= 50% RESIDUAL STENOSIS BY VISUAL ESTIMATE, >= 20 MM HG PEAK TRANSLESIONAL PRESSURE GRADIENT, >= 10 MM HG MEAN TRANSLESIONAL PRESSURE GRADIENT, AND/OR GRADE D DISSECTION (A SPIRAL SHAPED FILLING DEFECT WITHIN THE LUMEN OF THE VESSEL) OR ANY DISSECTION WITH SIGNIFICANT COMPROMISE IN LUMEN FLOW.

    Classifications

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

    Product Code Device Name
    NIN Stent, Renal