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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 SYSTEM
Classification Nameintravascular radiation delivery system
Generic Namepercutaneous catheter, radionuclide brachytherapy source, remote controlled radionuclide applicator system
ApplicantGUIDANT CORP.
PMA NumberP000052
Supplement NumberS014
Date Received11/21/2002
Decision Date12/17/2002
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to include a warning statement in the instructions for use for the galileo iii centering catheter advising the user not to exceed a pressure of 4 atm, as possible overexpansion of the inflation lumen could result.
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