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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.
 
DeviceMOBILE SENOGRAPHE 2000D
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantGE Healthcare
3000 N. GRANDVIEW BLVD
WAUKESHA, WI 53188
PMA NumberP990066
Supplement NumberS008
Date Received10/26/2001
Decision Date12/18/2001
Reclassified Date 12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MAKE A MOBILE VERSION OF THE DEVICE, THAT IS CAPABLE OF MOVING FROM PLACE TO PLACE IN AN AIR-RIDE VAN AND ABLE TO TRANSMIT IMAGES FROM THESE LOCATIONS VIA A WIRELESS COMMUNICATIONS LINK.
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