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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.
 
DeviceSIEMENS MAMMOMAT INSPIRATION 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
Supplement NumberS006
Date Received10/13/2009
Decision Date11/05/2010
Reclassified Date 12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGING THE OEM COMPONENTS (DETECTOR AND IMAGE PROCESSING) DEVELOPED BY LORAD, THE MAMMOMAT NOVATION, TO AN FFDM SYSTEM THAT IS DESIGNED SOLELY FROM COMPONENTS DESIGNED OR SPECIFIED BY SIEMENS, THE MAMMOMAT INSPIRATION.
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