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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 MICROSPHERES
Generic NameMicrospheres radionuclide
ApplicantSirtex Medical, Inc.
300 Unicorn Park Dr., 2nd Floor ,
Woburn, MA 01801
PMA NumberP990065
Supplement NumberS008
Date Received01/15/2015
Decision Date02/27/2015
Product Code NAW 
Advisory Committee Radiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF A NEW CLEANROOM WITH TWO NEW PRODUCTION HOT CELLS AND ASSOCIATED EQUIPMENT TO EXISTING MANUFACTURING SPACE.
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