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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 AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
Generic NameIntravascular radiation delivery system
ApplicantGUIDANT CORP.
26531 YNEZ RD.
TEMECULA, CA 92591-4630
PMA NumberP000052
Supplement NumberS019
Date Received06/30/2003
Decision Date07/24/2003
Withdrawal Date 01/31/2008
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE FOLLOWING CHANGES TO THE LABELING: 1) ADDING A WARNING STATEMENT ALERTING USERS TO THE POTENTIAL FOR A RADIATION OVERDOSE IF AN INTERRUPTED TREATMENT IS NOT RESUMED APPROPRIATELY. 2) MODIFYING THE EMERGENCY RESPONSE PROCEDURES TO ASSIST USERS TO RETRACT THE ACTIVE WIRE IN THE MOST EXPEDITIOUS MANNER WHILE MAINTAINING SAFETY OF THE PATIENT AND THE RADIATION PERSONNEL INVOLVED IN CASE OF AN EMERGENCY.
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