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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.
Classification Namedigital breast tomosynthesis
Generic Namedigital breast tomosynthesis
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, MA 01730
PMA NumberP080003
Supplement NumberS005
Date Received05/02/2017
Decision Date05/23/2017
Product Code
OTE[ Registered Establishments with OTE ]
Advisory Committee Radiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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.
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