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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
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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