BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P980037 · Supplement: S024 · Decision Jun 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEN
    PMA Number
    P980037
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    MCX
    Generic Name
    CATHETER, CORONARY, ATHERECTOMY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 17, 2008
    Date Received
    December 20, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATIVE HYDROPHILIC COATING MATERIAL AND SUPPLIER (DSM BIOMEDICAL, GLEEN, NETHERLANDS) USED ON THE DISTAL SHAFT OF THE SPIROFLEX FAMILY OF CATHETERS (SPIROFLEX AND SPRIOFLEX VG) AND APPROVAL TO PERFORM THE MANUFACTURING COATING PROCESS OF THE NEW DSM HYDROPHILIC COATING AT THE POSSIS FACILITY, MINNEAPOLIS, MINNESOTA.

    Classifications

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

    Product Code Device Name
    MCX Catheter, Coronary, Atherectomy