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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.
 
DeviceSENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
Applicant
GE Healthcare
3000 n. grandview blvd
waukesha, WI 53188
PMA NumberP990066
Supplement NumberS026
Date Received12/01/2006
Decision Date01/03/2007
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the labeling regarding the placement of the laterality and view marker that fda approved under p990066/s022.
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