BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P030047 · Supplement: S011 · Decision Sep 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    CORDIS PRECISE NITINOL STENT SYSTEM & RX NITINOL STENT & PRO RX NITINOL STENT SYSTEM
    PMA Number
    P030047
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    NIM
    Generic Name
    Stent, carotid
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 30, 2008
    Date Received
    February 5, 2008
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REDUCING THE SAMPLE SIZE FOR THE FOLLOWING PROCESSES: 1) THE FUSING OPERATION FOR ALL PRECISE DEVICES AND THE SEALING OPERATION FOR PRECISE RX; AND 2) THE BONDING PROCESS OF THE PRECISE RX AND PRECISE PRO RX SUPPORT MEMBER/WIRE LUMEN SUBASSEMBLY.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid