BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P000018 · Supplement: S025 · Decision Jan 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Intravascular Radiation Delivery System
    Trade Name
    NOVOSTE BETA-CATH SYSTEM
    PMA Number
    P000018
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    MOU
    Generic Name
    Intravascular radiation delivery system
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 6, 2003
    Date Received
    October 15, 2002
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATION AND MANUFACTURING PROCESS FOR THE BETA-RAIL 3.5F DELIVERY CATHETER (WITH 30 AND 40 MM INDICATOR SOURCE TRAIN).

    Classifications

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

    Product Code Device Name
    MOU Intravascular Radiation Delivery System