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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.
 
DeviceSELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantHOLOGIC, INC.
36 Apple Ridge Road
Danbury, CT 06810
PMA NumberP010025
Supplement NumberS004
Date Received12/19/2003
Decision Date03/02/2004
Reclassified Date 12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SELENIA FFDM SYSTEM FOR USE IN A MOBILE ENVIRONMENT AND QC MANUAL CHANGES.
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