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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.
 
DeviceTheraSphere
Generic NameMicrospheres radionuclide
ApplicantBoston Scientific Corporation
300 Boston Scientific Way
Marborough, MA 01752
PMA NumberP200029
Supplement NumberS006
Date Received11/08/2023
Decision Date02/06/2024
Product Code NAW 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the labeling which included updates to address new quality system requirements, MR safe labeling, and clarifications in the user manuals.
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