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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital mammography system
Regulation Number892.1715
ApplicantSIEMENS MEDICAL SOLUTION
PMA NumberP030010
Supplement NumberS003
Date Received10/26/2005
Decision Date02/15/2006
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the siemens mammomat novationdr full field digital mammography system (mammomat novationdr) in a mobile environment.
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