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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.
DeviceSelenia Dimensions / 3Dimensions
Generic Namedigital breast tomosynthesis
ApplicantHOLOGIC, INC.
35 crosby dr.
bedford, MA 01730
PMA NumberP080003
Supplement NumberS007
Date Received05/02/2018
Decision Date06/22/2018
Product Code OTE 
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change to the Selenia Dimensions/3Dimensions detector subsystem for approval of a new Application Specific Integrated Circuit (ASIC), and also the necessary changes to some of the detector PCB hardware, detector embedded software and detector firmware in order to support dual sourcing.