|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||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to include updating manufacturing documents, work instructions, and test procedures. Also, high level assembly of some subcomponents will be performed by plexus corporation.