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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 3D System.
Generic NameDigital breast tomosynthesis
ApplicantHOLOGIC, INC.
PMA NumberP080003
Supplement NumberS005
Date Received05/02/2017
Decision Date05/23/2017
Product Code OTE 
Advisory Committee Radiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change to the Physician Labeling of the Selenia Dimensions 3D System and the Selenia Dimensions 3D System with C-View Software Module, to claim superior screening accuracy of 3D plus 2D imaging, where the 2D image can be either a synthesized 2D or a Full Field Digital Mammography (FFDM) image, as compared to FFDM alone, for women with dense breasts.