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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 RADIOTHERPY SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantGUIDANT CORP.
26531 YNEZ RD.
TEMECULA, CA 92591-4630
PMA NumberP000052
Supplement NumberS005
Date Received02/21/2002
Decision Date08/22/2002
Withdrawal Date 01/31/2008
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR HARDWARE AND SOFTWARE CHANGES FOR THE GALILEO SOURCE DELIVERY UNIT, I.E., AN ALTERNATE PRIMARY CIRCUIT BOARD (AMPRO BOARD), LCD DISPLAY AND ASSOCIATED SOFTWARE. THESE CHANGES ARE APPLICABLE TO THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM, WHICH CONSISTS OF THE GALILEO SOURCE DELIVERY UNIT, THE 27 MM 32P SOURCE WIRE AND THE 27 MM GALILEO CENTERING CATHETER.
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