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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.
 
DeviceSIR-Spheres Y-90 resin microspheres
Generic NameMicrospheres radionuclide
ApplicantSirtex Medical, Inc.
300 Unicorn Park Dr., 2nd Floor ,
Woburn, MA 01801
PMA NumberP990065
Supplement NumberS014
Date Received01/16/2024
Decision Date07/01/2025
Product Code NAW 
Docket Number 25M-2080
Notice Date 07/01/2025
Advisory Committee Radiology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
SIR-Spheres® Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child Pugh-A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intrahepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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