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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 (TM) III INTRAVASCULAR RADIOTHERAPY SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantGUIDANT CORP.
26531 YNEZ RD.
TEMECULA, CA 92591-4630
PMA NumberP000052
Supplement NumberS004
Date Received12/11/2001
Decision Date09/19/2002
Withdrawal Date 01/31/2008
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM AND IS INDICATED AS FOLLOWS: "THE GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM IS INTENDED 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 A REFERENCE VESSEL DIAMETER 2.4 MM TO 3.7 MM."
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