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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.
 
DeviceGEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantGE Healthcare
3000 N. Grandview Blvd.
Waukesha, WI 53188
PMA NumberP990066
Supplement NumberS013
Date Received05/13/2002
Decision Date06/05/2002
Reclassified Date12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF A SIEMENS MODEL 6GF6300-1BW04 AWS MONITOR WITH PDS CRT AS AN ALTERNATIVE SUPPLIER OF THE AWS MONITOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM AND SUPPRESSION OF THE AWS MONITOR CALIBRATION TEST.
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