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

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P860019 · Supplement: S170 · Decision Apr 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    MAVERICK MONORAIL
    PMA Number
    P860019
    Supplement Number
    S170
    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 5, 2001
    Date Received
    March 13, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES IN THE MANUFACTURING PROCESS FOR THE MAVERICK MONORAIL PRODUCT LINE TO INCLUDE THE USE OF A NON-TAPERED PRODUCTION MANDREL WITH BLUNT ENDS, AND ADDITIONAL PREVENTIVE MEASURES TO ENSURE THAT A THIN WALL CONDITION DOES NOT OCCUR IN THE INFLATION LUMEN, ICLUDING THE ADDITION OF A 100% VACUUM DECAY TEST FOR BOTH THE MAVERICK MONORAIL AND OVER-THE-WIRE PTCA 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