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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 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 NumberS022
Date Received11/18/2003
Decision Date12/18/2003
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing process for guidant's p-32 source wire by using an alternate needle coating process and material.
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