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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 System
Generic NameDigital breast tomosynthesis
ApplicantSiemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern, PA 19355
PMA NumberP140011
Supplement NumberS007
Date Received01/29/2020
Decision Date08/21/2020
Product Code OTE 
Advisory Committee Radiology
Clinical TrialsNCT01373671
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for 1) a new processing scheme for synthetic mammograms (new Insight 2D/3D), and 2) an updated Indications for Use to include Digital Breast Tomosynthesis (DBT) in combination with synthesized image sets, Insight 2D, or Insight 2D and Insight 3D, as a screening mode, for MAMMOMAT Revelation with Tomosynthesis Option.
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