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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
ApplicantU-SYSTEMS, INC.
9900 WEST INNOVATIVE DRIVE
MAIL STOP RP2138
WAUWATOSA, WI 53226
PMA NumberP110006
Supplement NumberS005
Date Received02/27/2015
Decision Date04/13/2015
Product Code PAA 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN APPLICATIONS TRAINING PROGRAM FOR THE INVENIA ABUS AUTOMATED BREAST ULTRASOUND SYSTEM. TWO ADDITIONAL TRAINING PROGRAMS WERE PROPOSED. THE FIRST ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR ONE TECHNOLOGIST/SCAN OPERATOR, EQUIVALENT TO THE PREVIOUSLY-APPROVED THREE-DAY PROGRAM FOR THREE TECHNOLOGISTS/SCAN OPERATORS. THE SECOND ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR A DESIGNATED SITEOPERATIONS SPECIALIST WHO IS EXPERIENCED IN INVENIA ABUS BREAST EXAMS, AND IS QUALIFIED FOR THE TRAINING ACCORDING TO A SET OF SPECIFIED REQUIREMENTS OUTLINED BY THE SPONSOR.
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