BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P910031 · Supplement: S011 · Decision Apr 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS
    PMA Number
    P910031
    Supplement Number
    S011
    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
    April 9, 1997
    Date Received
    August 26, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING: 1) A CHANGE IN THE BALLOON DESIGN FROM A DOUBLE LAYER OF POLYETHYLENE WITH A POLYETHYLENE TEREPHALATE CENTER REGION TO A SINGLE LAYER OF POLYETHYLENE TEREPHALATE; 2) A CHANGE IN CATHETER SHAFT MATERIAL FROM POLYETHYLENE TO NYLON; 3) A CHANGE IN THE INTERNAL SHAFT DESIGN FROM A TWO LUMEN SIDE BY SIDE DESIGN TO A TWO LUMEN COAXIAL DESIGN; 4) A CHANGE IN THE BALLOON/SHAFT BONDING METHOD FROM HEAT SEALING TO A URETHANE ADHESIVE; 5) A CHANGE IN THE BALLOON LENGTHS FROM 25 MM TO 22 MM AND FROM 20 MM TO 18 MM; AND 6) A CHANGE IN THE COLOR OF THE CATHETER SHAFT FROM BLUE TO TEAL.

    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