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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceGALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantGUIDANT CORP.
26531 YNEZ RD.
TEMECULA, CA 92591-4630
PMA NumberP000052
Date Received12/18/2000
Decision Date11/02/2001
Withdrawal Date 01/31/2008
Product Code MOU 
Docket Number 01M-0508
Notice Date 11/14/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM WHICH CONSISTS OF THE GALILEO SOURCE DELIVERY UNIT, 27 MM GALILEO CENTERING CATHETER, AND 27 MM 32P SOURCE WIRE. THE DEVICE IS INDICATED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS <= 47 MM IN REFERENCE VESSEL DIAMETER 2.4 MM TO 3.7 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 
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