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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
Classification Namedigital breast tomosynthesis
Generic Namedigital breast tomosynthesis
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, MA 01730
PMA NumberP080003
Supplement NumberS007
Date Received05/02/2018
Decision Date06/22/2018
Product Code
OTE[ Registered Establishments with OTE ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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.
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