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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSIR-SPHERES
Generic NameMicrospheres radionuclide
ApplicantSirtex Medical Pty Ltd
Shop 6 207 Pacific Highway
St Leonards, New South Wales 2065
PMA NumberP990065
Date Received10/25/1999
Decision Date03/05/2002
Product Code NAW 
Docket Number 03M-0010
Notice Date 01/23/2003
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR SIR-SPHERES. THE DEVICE IS INDICATED FOR THE TREATMENT OF UNRESECTABLE METASTATIC LIVER TUMORS FROM PRIMARY COLORECTAL CANCER WITH ADJUVANT INTRA-HEPATIC ARTERY CHEMOTHERAPY (IHAC) OF FUDR (FLOXURIDINE).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S007  S006 S008 S001 S010 S004 S009 S012 S013 S015 
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