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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 INTRAVASCULAR RADIOTHERAPY SYSTEM
Classification Nameintravascular radiation delivery system
Generic Namepercutaneous catheter, radionuclide brachytherapy source, remote controlled radionuclide applicator system
ApplicantGUIDANT CORP.
PMA NumberP000052
Supplement NumberS010
Date Received07/05/2002
Decision Date08/02/2002
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Amending implementation of manufacturing changes described in p000052/s007, approved april 17, 2002 and adding a verification step to the preventive maintenance checklist for the galileo source delivery unit.
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