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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
Classification Namemicrospheres radionuclide
Generic Namemicrospheres radionuclide
Applicant
SIRTEX MEDICAL LIMITED
level 33, 101 miller street
north sydney nsw 2060 
PMA NumberP990065
Date Received10/25/1999
Decision Date03/05/2002
Product Code
NAW[ Registered Establishments with NAW ]
Docket Number 03M-0010
Notice Date 01/23/2003
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S004 S006 S007 S008 S009 S010 
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