BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P860019 · Supplement: S181 · Decision Apr 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    MAVERICK MONORAIL/OVER THE WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PICA) CATHETERS
    PMA Number
    P860019
    Supplement Number
    S181
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 24, 2002
    Date Received
    April 10, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATE MANUFACTURING PROCESS TO PRODUCE BALLOONS FOR THE MAVERICK MONORAIL PTCA CATHETER AND THE MAVERICK OTW PTCA CATHETER. THE ALTERNATE PROCESS AFFECTS ONLY THE METHOD OF STRETCHING THE BALLOON TUBING PRIOR TO MOLDING THE BALLOON.

    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