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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSIR-SPHERES
Classification Namemicrospheres radionuclide
ApplicantSIRTEX MEDICAL LIMITED
PMA NumberP990065
Supplement NumberS001
Date Received03/25/2003
Decision Date04/24/2003
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional warning on the label.
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