BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P910019 · Supplement: S003 · Decision Jan 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
    PMA Number
    P910019
    Supplement Number
    S003
    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
    January 29, 1998
    Date Received
    October 28, 1997
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N
    Docket Number
    N

    Advisory Committee Statement

    Approval for a change to the 5.5F TEC(R) cutter catheter, involving an increase in the skirt length of the cutter component from 0.079 inches to 0.104 inches.

    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