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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.
 
DeviceEnvision Mammography Platform
Generic NameDigital breast tomosynthesis
ApplicantHologic, Inc.
35 Crosby Dr.
Bedford, MA 01730
PMA NumberP080003
Supplement NumberS011
Date Received10/24/2025
Decision Date11/24/2025
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 located at Hologic, Inc., 600 Technology Drive, Newark, DE 19702-2463.
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