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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 Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option
Generic NameDigital breast tomosynthesis
ApplicantSiemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern, PA 19355
PMA NumberP140011
Supplement NumberS005
Date Received08/21/2017
Decision Date09/29/2017
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 a change to the detector, updated detector (LMAM2V2) with new electronic circuits for read-out.
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