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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
Generic NameDigital breast tomosynthesis
ApplicantSIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN, PA 19355-1406
PMA NumberP140011
Date Received06/26/2014
Decision Date04/21/2015
Product Code OTE 
Docket Number 15M-1460
Notice Date 05/18/2015
Advisory Committee Radiology
Clinical TrialsNCT01373671
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION. THIS DEVICE IS INDICATED FOR THE ACQUISITION OF 2D AS WELL AS 3D DIGITAL MAMMOGRAPHY IMAGES TO BE USED IN SCREENING AND DIAGNOSIS OF BREAST CANCER. EACH SCREENING EXAMINATION MAY CONSIST OF CC AND MLO VIEWS IN: A 2D IMAGE SET, OR A 2D AND 3D IMAGE SET. NOTE: THE SCREENING EXAMINATION MAY CONSIST OF 2D FFDM IMAGES SET WITH OR WITHOUT THE 3D IMAGE SET.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S005 S006 S007 
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