BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P860019 · Supplement: S182 · Decision Oct 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS
    PMA Number
    P860019
    Supplement Number
    S182
    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
    October 1, 2002
    Date Received
    April 16, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE QUANTUM MAVERICK MONORAIL AND OTW PTCA CATHETERS AND APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY, COSMED OF RI, COVENTRY, RHODE ISLAND. THE QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS ARE AVAILABLE IN LENGTHS OF 8, 12, 15, 20 AND 30 MM, WITH DIAMETERS RANGING FROM 2.00 TO 4.00 MM IN 1/4MM INCREMENTS AND 4.5 TO 5.0 MM IN 1/2 MM INCREMENTS (EXCEPT FOR THE 20 MM LENGTH). THE DEVICES, AS MODIFIED, ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION AND FOR THE POST DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.

    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