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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.
 
DeviceHOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantHologic, Inc.
36 Apple Ridge Rd.
Danbury, CT 06810
PMA NumberP010025
Supplement NumberS008
Date Received10/24/2005
Decision Date03/29/2006
Reclassified Date12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN OPTIONAL PRODUCT CONFIGURATION OF TUNGSTEN TARGET WITH RHODIUM AND SILVER FILTERS IN THE X-RAY SYSTEM INSTEAD OF MOLYBDENUM TARGET WITH MOLYBDENUM AND RHODIUM FILTERS.
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