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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 AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantGE Healthcare
3000 N. GRANDVIEW BLVD
WAUKESHA, WI 53188
PMA NumberP990066
Supplement NumberS025
Date Received09/27/2006
Decision Date10/20/2006
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 GE HEALTHCARE/FINLAND AS AN ALTERNATE SUPPLIER FOR THE X-RAY BUCKYS USED ON THE DEVICE.
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