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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
Classification Namemicrospheres radionuclide
Generic Namemicrospheres radionuclide
Applicant
SIRTEX MEDICAL LIMITED
level 33, 101 miller street
north sydney nsw 2060 
PMA NumberP990065
Supplement NumberS006
Date Received09/19/2011
Decision Date07/17/2012
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIRTEX SINGAPORE PTE LTD. IN SINGAPORE.
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