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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.
 
DeviceInvenia ABUS Autoated Breast Ultrasound System
Generic NameAutomated breast ultrasound
ApplicantGE Healthcare
9900 Innovation Dr.
Wauwatosa, WI 53226
PMA NumberP110006
Supplement NumberS008
Date Received02/28/2017
Decision Date09/07/2017
Product Code PAA 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site change to GE Parallel Design Inc., 4313 E Cotton Center Blvd., Suite 100, Phoenix Arizona.
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