BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P000018 · Supplement: S026 · Decision Nov 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Intravascular Radiation Delivery System
    Trade Name
    NOVOSTE BETA-CATH 3.5F SYSTEM
    PMA Number
    P000018
    Supplement Number
    S026
    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
    November 13, 2002
    Date Received
    October 18, 2002
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE USER'S MANUAL, USER'S GUIDE AND CUSTOMER TRAINING TO INCLUDE ADDITIONAL INFORMATION ON SCENARIOS WHERE THE BETA-RAIL 3.5F DELIVERY CATHETER TIP MAY BE SUBJECTED TO EXCESSIVE FORCE AND THE TECHNIQUES FOR AVOIDING AND/OR RESOLVING THESE SCENARIOS.

    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