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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 High Resolution Tomosynthesis
Generic NameDigital breast tomosynthesis
ApplicantHOLOGIC, INC.
PMA NumberP080003
Supplement NumberS008
Date Received04/04/2019
Decision Date10/24/2019
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 software option 3DQuoromTM technology, which generates thicker 6 mm slices (also referred as SmartSlices or slabs) and change to the indications for use statement as a result of this update.