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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 TOMOSYNTHESIS OPTION
Generic NameDigital breast tomosynthesis
ApplicantSiemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern, PA 19355
PMA NumberP140011
Supplement NumberS002
Date Received12/23/2015
Decision Date01/13/2016
Product Code OTE 
Advisory Committee Radiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO IMPLEMENT A SOFTWARE UPDATE THAT RESOLVES AN ERROR THAT MAY OCCUR DURING TOMOSYNTHESIS RECONSTRUCTION WITH A BREAST THICKNESS LARGER THAN 90 MM.
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