BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intravascular Radiation Delivery System

    PMA: P000018 · Supplement: S028 · Decision Jun 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Intravascular Radiation Delivery System
    Trade Name
    BETA-CATH 3.5F SYSTEM - 60 MM
    PMA Number
    P000018
    Supplement Number
    S028
    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
    June 25, 2003
    Date Received
    January 6, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE 60 MM BETA-CATH 3.5F SYSTEM. THE DEVICE, AS MODIFIED, IS INDICATED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS (TREATABLE WITH A 20 MM BALLOON FOR THE 30 MM AND 40 MM SYSTEMS AND INJURY AREAS UP TO 40 MM FOR THE 60 MM SYSTEM) IN A REFERENCE VESSEL DIAMETER RANGING FROM 2.7 MM TO 4.0 MM.

    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