BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P860019 · Supplement: S154 · Decision Apr 5, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    ADANTE PTCA CATHETER
    PMA Number
    P860019
    Supplement Number
    S154
    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
    April 5, 1999
    Date Received
    March 15, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the ADANTE(TM) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (20 mm length with balloon diameters of 1.5 mm, and 2.0 -4.0 mm in 1/4 mm increments, and 30 and 40 mm lengths with balloon diameters of 2.0 - 4.0 mm in 1/4 mm increments). The ADANTE(TM) PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocaridal perfusion. The ADANTE(TM) PTCA Catheter (balloon models 2.5 - 4.0 mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents.

    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