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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 (Automated Breast Ultrasound System) 2.0
Generic NameAutomated breast ultrasound
ApplicantGE Healthcare
9900 Innovation Dr.
Wauwatosa, WI 53226
PMA NumberP110006
Supplement NumberS010
Date Received11/29/2017
Decision Date08/24/2018
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 in Wuxi, China for U-Systems Invenia ABUS (Automated Breast Ultrasound System) 2.0, which includes a Scan Station (with automated transducer).
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