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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.
 
DeviceSIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantSIEMENS MEDICAL SOLUTION
51 VALLEY STREAM PKWY.
MALVERN, PA 19355
PMA NumberP030010
Date Received04/10/2003
Decision Date08/20/2004
Reclassified Date 12/06/2010
Product Code MUE 
Docket Number 04M-0387
Notice Date 09/03/2004
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE DEVICE GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER AND IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHIC SYSTEMS. THESE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY EITHER HARDCOPY FILM OR BY SOFTCOPY AT A WORKSTATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S006 S005 S003 S002 S001 S004 
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