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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
Classification Nameintravascular radiation delivery system
Generic Namepercutaneous catheter, radionuclide brachytherapy source, remote controlled radionuclide applicator system
ApplicantGUIDANT CORP.
PMA NumberP000052
Supplement NumberS019
Date Received06/30/2003
Decision Date07/24/2003
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product 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.
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