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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 INTRAVASCULAR RADIOTHERAPY SYSTEM
Classification Nameintravascular radiation delivery system
Generic Nameintravascular radiation delivery system
Applicant
GUIDANT CORP.
26531 ynez rd.
temecula, CA 92591-4630
PMA NumberP000052
Supplement NumberS007
Date Received03/18/2002
Decision Date04/17/2002
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGES RELATED TO THE DISPLAY STOP SCREW AND THE MOTOR COUPLING SCREW IN MANUFACTURING THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM.
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