BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P810046 · Supplement: S192 · Decision Oct 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    ACS RX SOLARIS CORONARY DILATATION CATHETER
    PMA Number
    P810046
    Supplement Number
    S192
    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
    October 16, 1998
    Date Received
    June 19, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the ACS RX SOLARIS(TM) Coronary Dilatation Catheter and a modification to the Instructions for Use for ACS PTCA Catheters. The ACS RX SOLARIS(TM) Coronary Dilatation Catheter is indicated for balloon dilatation of: 1) the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; and 2) a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction.

    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