BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P790017 · Supplement: S083 · Decision Jun 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    SPRINTER MX2 BALLOON DILATATION CATHETER
    PMA Number
    P790017
    Supplement Number
    S083
    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
    June 22, 2005
    Date Received
    December 10, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING A NEW CATHETER TO THE APPROVED PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPRINTER MX2 AND IS INDICATED FOR BALLOON DILATATION FOR THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE BALLOON DILATATION CATHETER (BALLOON MODELS 2.5 MM ? 4.0 MM) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS. NOTE: BENCH TESTING WAS CONDUCTED WITH THE SPRINTER BALLOON DILATATION CATHETER AND MARKETED BALLOON EXPANDABLE STENTS. CONSIDERATION SHOULD BE TAKEN WHEN THIS DEVICE IS USED WITH DIFFERENT MANUFACTURERS? STENTS DUE TO DIFFERENCES I STENT DESIGN.

    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