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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
Generic NameMicrospheres radionuclide
ApplicantSirtex Medical Pty Ltd
Shop 6 207 Pacific Highway
St Leonards, New South Wales 2065
PMA NumberP990065
Supplement NumberS001
Date Received03/25/2003
Decision Date04/24/2003
Product Code NAW 
Advisory Committee Radiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR ADDITIONAL WARNING ON THE LABEL.
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