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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 NameSENOGRAPHE ESSENTIAL SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namedigital mammographic x-ray system
Regulation Number892.1715
ApplicantGE HEALTHCARE
PMA NumberP990066
Supplement NumberS024
Date Received08/02/2006
Decision Date09/01/2006
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add statements to the user and installation instructions to caution about the equipment that may not properly display or print the larger images produced by the senographe essential.
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