BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P870036 · Supplement: S043 · Decision Aug 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER
    PMA Number
    P870036
    Supplement Number
    S043
    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
    August 12, 1997
    Date Received
    March 3, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: A) THE ADDITIO OF 15 MM LENGTHS TO THE MILLENIA(TM) CORONARY BALLOON DILATATION CATHETER LINE; B) A CHANGE IN THE METHOD USED TO TEST FOR BURST STRENGTH OF THE BALLOONS; AND C) THE ADDITION OF THE FOLIO BALLOON SHAPING TOOL AS AN ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC(R) MILLENIA(TM) 15 CORONARY BALLOON DILATATION CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.

    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