BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P880027 · Supplement: S036 · Decision Nov 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER
    PMA Number
    P880027
    Supplement Number
    S036
    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
    November 21, 1995
    Date Received
    May 19, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING:1)NEW LABELING WHICH COMPLIES TO THE FDA'S PTCA PACKAGE INSERT TEMPLATE 2)ALTERNATIVE PACKAGING DESIGN AND MATERIALS 3)A CHANGE IN THE MATERIAL OF THE PROXIMAL TO DISTAL INNER MEMBER TRANSITION SLEEVE 4)ADDITION OF 2.25, 2.75, 3.25, AND 3.75 MM BALLOONS WITH LENGTHS OF 20, 30, AND 40MM 5)AN INCREASE IN THE INNER AND OUTER DIAMETERS OF THE PROXIMAL SHAFT AND DISTAL STEM OF THE CATHETERS HAVING 20 MM BALLOONS 6)AN ALTERNATIVE DESIGN CONFIGURATION WHICH PLACES THE SHAFT TO STEM BOND DISTAL TO THE INNER MEMBER HYPOTUBE TRANSITION, NOT PROXIMAL

    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