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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 Premium, Invenia ABUS Prime
Generic NameAutomated breast ultrasound
ApplicantGE Healthcare
9900 Innovation Dr.
Wauwatosa, WI 53226
PMA NumberP110006
Supplement NumberS011
Date Received07/15/2024
Decision Date02/04/2025
Product Code PAA 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for modification of the currently-approved transducer, addition of a new transducer, hardware changes, addition of two new device names, and addition of two new features: Auto Nipple Detection, and Scan Quality Assessment.
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