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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namedigital mammographic x-ray system
Regulation Number892.1715
ApplicantGE MEDICAL SYSTEMS
PMA NumberP990066
Supplement NumberS011
Date Received02/07/2002
Decision Date02/22/2002
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a supplier for the gantry electronic boards of the senographe 2000d ffdm system. There will be no labeling changes or design changes to the specifications of the finished device.
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