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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 NumberS004
Date Received05/15/2006
Decision Date01/18/2008
Product Code NAW 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING AND STERILIZATION SITE LOCATED IN WILMINGTON, MASSACHUSETTS.
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