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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
Generic NameAutomated breast ultrasound
ApplicantU-SYSTEMS, INC.
9900 WEST INNOVATIVE DRIVE
MAIL STOP RP2138
WAUWATOSA, WI 53226
PMA NumberP110006
Supplement NumberS002
Date Received01/17/2014
Decision Date02/11/2014
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 CHANGE IN THE LABELING MATERIALS (REVISED SCAN STATION USER¿S MANUAL, WORKSTATION USER¿S MANUAL, AND USER TRAINING PROGRAM, AS WELL AS NEW PATIENT POSITIONING GUIDE, QUICK REFERENCE GUIDE ¿ POSITIONING, PRODUCT DATASHEET, AND BASIC SERVICE MANUAL).
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