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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) INTRAVASCULAR RADIOTHERAPY SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantGuidant Corp.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP000052
Supplement NumberS001
Date Received11/20/2001
Decision Date12/18/2001
Withdrawal Date01/31/2008
Product Code MOU 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATION OF A MANUFACTURING PROCESS, INCORPORATING ADDITIONAL ENVIRONMENTAL CONTROLS, FOR THE GDT-P32-2 (27 MM) SOURCE WIRE COMPONENT OF THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM.
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