BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P040012 · Supplement: S008 · Decision Mar 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
    PMA Number
    P040012
    Supplement Number
    S008
    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
    March 27, 2006
    Date Received
    February 24, 2006
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF A NEW CATHETER LEAK TEST TO THE MANUFACTURING PROCESS; 2) MODIFICATIONS TO THE RADIO FORCE IN-PROCESS TESTING PARAMETERS; 3) INCREASING THE STRINGENCY OF THE AQL FOR THE DISTAL JUNCTION TEST; 4) ADDITION OF A MICROSCOPIC VISUAL INSPECTION STEP TO DETECT BROKEN STRUTS; AND 5) ADDITION OF AN INSPECTION STEP TO VERIFY THAT THE ADHESIVE WAS CORRECTLY APPLIED AND COMPLETELY CURED.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid