BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Angioplasty, Peripheral, Transluminal

    PMA: P950020 · Supplement: S012 · Decision Mar 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94

    Basic Information

    Device Name
    Catheter, Angioplasty, Peripheral, Transluminal
    Trade Name
    ULTRA2 CUTTING BALLOON MONORAIL(MR)
    PMA Number
    P950020
    Supplement Number
    S012
    Device Class
    FDA Class 2
    Product Code
    LIT
    Generic Name
    Catheter, angioplasty, peripheral, transluminal
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 16, 2005
    Date Received
    November 8, 2004
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MANUFACTURING SITES LOCATED AT INTERVENTIONAL TECHNOLOGIES EUROPE, LTD., DONEGAL, IRELAND AND EBIS IOTRON, LTD., OXON, GREAT BRITAIN.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LIT Catheter, Angioplasty, Peripheral, Transluminal