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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 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
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 NumberS006
Date Received09/04/2001
Decision Date10/01/2001
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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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