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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
Generic NameAutomated breast ultrasound
ApplicantGE Healthcare
9900 Innovation Dr.
Wauwatosa, WI 53226
PMA NumberP110006
Supplement NumberS007
Date Received08/03/2016
Decision Date05/01/2017
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  
Approval for a change to the labeling to allow the use of ultrasound gel in addition to currently required ultrasound lotion with the system
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