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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 NumberS004
Date Received05/15/2006
Decision Date01/18/2008
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing and sterilization site located in wilmington, massachusetts.
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