BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Renal

    PMA: P100028 · Decision Jan 14, 2011
    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
    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 14, 2011
    Date Received
    July 19, 2010
    Expedited Review
    N
    Docket Number
    11M-0056

    Advisory Committee Statement

    APPROVAL FOR THE FORMULA BALLOON- EXPANDABLE RENAL STENT SYSTEM. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES FOLLOWING SUB-OPTIMAL PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) OF A DE NOVO OR RESTENOTIC LESION (<= 18 MM IN LENGTH) LOCATED WITHIN 10 MM OF THE RENAL OSTIUM AND WITH A REFERENCE VESSEL DIAMETER OF 4.0 - 7.0 MM. SUPOPTIMAL PTRA IS DEFINED AS >= 50% RESIDUAL STENOSIS, >= 20 MMHG SYSTOLIC OR >= 10 MMHG MEAN TRANSLESIONAL PRESSURE GRADIENT, OR FLOW-LIMITING DISSECTION.

    Classifications

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

    Product Code Device Name
    NIN Stent, Renal