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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.
 
Device3Dimensions
Classification Namedigital breast tomosynthesis
Generic Namedigital breast tomosynthesis
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, MA 01730
PMA NumberP080003
Supplement NumberS004
Date Received03/30/2017
Decision Date04/20/2017
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 Selenia Dimensions name to 3Dimensions.
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