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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 SYSTEMS
Classification Nameintravascular radiation delivery system
Generic Nameintravascular radiation delivery system
Applicant
GUIDANT CORP.
26531 ynez rd.
temecula, CA 92591-4630
PMA NumberP000052
Supplement NumberS022
Date Received11/18/2003
Decision Date12/18/2003
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE MANUFACTURING PROCESS FOR GUIDANT'S P-32 SOURCE WIRE BY USING AN ALTERNATE NEEDLE COATING PROCESS AND MATERIAL.
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