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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantGUIDANT CORP.
26531 YNEZ RD.
TEMECULA, CA 92591-4630
PMA NumberP000052
Supplement NumberS014
Date Received11/21/2002
Decision Date12/17/2002
Withdrawal Date 01/31/2008
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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