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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
Generic NameIntravascular radiation delivery system
ApplicantGuidant Corp.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP000052
Supplement NumberS016
Date Received01/17/2003
Decision Date06/27/2003
Withdrawal Date01/31/2008
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SOURCE BLANK SUBASSEMBLY. THE FACILITY IS LOCATED AT GUIDANT CORPORATION, HOUSTON, TEXAS.
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