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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
Generic NameIntravascular radiation delivery system
ApplicantGuidant Corp.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP000052
Supplement NumberS022
Date Received11/18/2003
Decision Date12/18/2003
Withdrawal Date01/31/2008
Product Code MOU 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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