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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 3D System
Generic Namedigital breast tomosynthesis
ApplicantHOLOGIC, INC.
35 crosby dr.
bedford, MA 01730
PMA NumberP080003
Supplement NumberS006
Date Received09/15/2017
Decision Date03/23/2018
Product Code OTE 
Advisory Committee Radiology
Supplement Typenormal 180 day track
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 3D System with 15 projection angles for approval of the high resolution tomosynthesis and synthesized 2D feature, SmartCurve compression paddles, as well as a new linear grid for the Full-field Digital Mammography System.