|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 Name||INVENIA ABUS|
|Classification Name||automated breast ultrasound|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| 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).