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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 SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantGuidant Corp.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP000052
Supplement NumberS023
Date Received01/09/2004
Decision Date03/16/2004
Withdrawal Date01/31/2008
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO IMPLEMENT A NEW SOFTWARE REVISION, VERSION 63-033/N. THE SOFTWARE WAS REVISED TO INCREASE THE DISTAL STOP FORCE OF THE ACTIVE SOURCE WIRE.
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