BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Renal

    PMA: P060006 · Decision Dec 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Stent, Renal
    Trade Name
    BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
    PMA Number
    P060006
    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
    December 11, 2008
    Date Received
    February 21, 2006
    Expedited Review
    N
    Docket Number
    08M-0646

    Advisory Committee Statement

    APPROVAL FOR THE BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM. THE DEVICE IS INDICATED AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) OF A SINGLE DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESION (<=15 MM IN LENGTH) OF THE RENAL ARTERY, LOCATED WITHIN 5 MM OF THE OPACIFIED AORTIC LUMEN, WITH A REFERENCE VESSEL DIAMETER OF 4.0 ¿ 7.0 MM TO ASSIST IN THE MAINTENANCE OF VESSEL PATENCY.

    Classifications

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

    Product Code Device Name
    NIN Stent, Renal