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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.
 
DeviceMAMMOMAT Revelation with Tomosynthesis Option
Generic NameDigital breast tomosynthesis
ApplicantSiemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern, PA 19355
PMA NumberP140011
Supplement NumberS006
Date Received09/12/2019
Decision Date12/10/2019
Product Code OTE 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the detector software and the tomosynthesis reconstruction pipeline.
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