BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P810046 · Supplement: S194 · Decision Apr 14, 1999
    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
    S194
    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 14, 1999
    Date Received
    December 4, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for additional balloon sizes and an additional indication for use for the ACS RX Solaris(TM) Coronary Dilatation Catheter. The device as indicated for: a)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction. c) Balloon dilatation of the ACS MULTI-LINK DUET(TM) stent after implantation. This indication applies to the following balloon sizes and stent lengths: Ballon Size:3.0-4.0mmx9mm Stent Length: 13mm 3.0-4.0mmx15mm 18mm 3.0-4.0mmx20mm 23mm 3.0-4.0mmx25mm 28mm

    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