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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 NumberS009
Date Received08/31/2023
Decision Date07/05/2024
Product Code OTE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for introduction of Envision Mammography Platform that include updated gantry with adjustable tilted C-Arm, detector electronics, user interfaces, anti-scatter grid, dynamic collimator, and introduction of X-ray source with moving focal spot.
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