BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P880003 · Supplement: S052 · Decision Mar 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    TITAN AND TITAN XL PTCA DILATATION CATHETERS
    PMA Number
    P880003
    Supplement Number
    S052
    Device Class
    FDA Class 2
    Product Code
    LOX
    Generic Name
    Catheters, transluminal coronary angioplasty, percutaneous
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 13, 1996
    Date Received
    November 22, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1)TITAN AND TITAN XL PTCA DILATATION CATHETERS WITH 3.25MM AND 3.75MM DIAMETER BALLOONS AVAILABLE IN 9MM OR 18MM LENGTHS 2)A MODIFIED HUB BONDING PROCESS 3)A CHANGE IN THE DEVICE NAME FROM TITAN 18 PTCA DILATATION CATHEGTERS TO TITAN PTCA DILATATION CATHETERS 4)ONE SET OF INSTRUCTION FOR USE FOR ALL TITAN AND TITAN XL PTCA DILATATION CATHETERS

    Classifications

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

    Product Code Device Name
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous