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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.
 
DeviceSENOGRAPHE DS & 2000D FFDM SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantGE Healthcare
3000 N. GRANDVIEW BLVD
WAUKESHA, WI 53188
PMA NumberP990066
Supplement NumberS022
Date Received09/13/2005
Decision Date10/17/2005
Reclassified Date 12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ADD LABELING ALERTING USER THAT IMAGES MAY BE DISPLAYED IN A MANNER DIFFERENT FROM THAT SPECIFIED IN MQSA REQUIREMENTS.
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