|Trade Name||GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS|
|Classification Name||intravascular radiation delivery system|
|Generic Name||percutaneous catheter, radionuclide brachytherapy source, remote controlled radionuclide applicator system|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of the following changes to the labeling: 1) adding a warning statement alerting users to the potential for a radiation overdose if an interrupted treatment is not resumed appropriately. 2) modifying the emergency response procedures to assist users to retract the active wire in the most expeditious manner while maintaining safety of the patient and the radiation personnel involved in case of an emergency.