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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 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantGE Healthcare
3000 N. GRANDVIEW BLVD
WAUKESHA, WI 53188
PMA NumberP990066
Supplement NumberS006
Date Received09/04/2001
Decision Date10/01/2001
Reclassified Date 12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF A SUPPLIER FOR THE COLUMN MOUNTED ON THE SENOGRAPHE 2000D SYSTEM. THERE WILL BE NO IMPACT ON THE MANUFACTURING PROCESSES (ASSEMBLY AND TESTING). THERE ARE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.
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