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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINVENIA ABUS
Classification Nameautomated breast ultrasound
ApplicantU-SYSTEMS, INC.
PMA NumberP110006
Supplement NumberS002
Date Received01/17/2014
Decision Date02/11/2014
Product Code
PAA[ Registered Establishments with PAA ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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