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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
Generic NameDigital breast tomosynthesis
ApplicantHologic, Inc.
35 Crosby Dr.
Bedford, MA 01730
PMA NumberP080003
Supplement NumberS010
Date Received12/19/2023
Decision Date05/29/2024
Product Code OTE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site change to Hologic, Inc., 600 Technology Drive, Newark, DE 19702-2463.
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