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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 FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namedigital breast tomosynthesis
Generic Namedigital breast tomosynthesis
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, MA 01730
PMA NumberP080003
Supplement NumberS003
Date Received03/30/2016
Decision Date07/07/2016
Product Code
OTE[ Registered Establishments with OTE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 30 projection tomosynthesis feature.
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