BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P810046 · Supplement: S171 · Decision May 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    ACS RX COMET CORONARY DILATION CATHETER
    PMA Number
    P810046
    Supplement Number
    S171
    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
    May 12, 1997
    Date Received
    December 23, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ACS RX COMET(TM) CORONARY DILATATION CATHETER WITH THE 40 MM BALLOON LENGTHS WITH THE HALF SIZES (I.E., 2.0 MM, 2.5 MM, 3.0 MM, 3.5 MM, 4.0 MM), THE 15 MM BALLOON LENGTHS WITH THE QUARTER SIZES (I.E., 2.75 MM, 3.25 MM AND 3.75 MM DIAMETERS), THE 30 MM BALLOON LENGTHS (I.E., 2.75 MM, 3.25 MM, 3.75 MM AND 4.0 MM DIAMETERS) AND A SINGLE 20 MM BALLOON LENGTH (I.E., 1.5 MM) AND MODIFICATION OF THE BALLOON COMPLIANCE CHART OF THE ACS RX COMET(TM) CORONARY DILATATION CATHETER TO INLCUDE DATA UP TO 18 ATM FOR BALLOONS WITH A RATED BURST PRESSURE (RBP) OF 14 ATM TO BE CONSISTENT WITH OTHER PTCA MANUFACTURERS.

    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