|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 -- AUTOMATED BREAST ULTRASOUND SYSTEM|
|Classification Name||automated breast ultrasound|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes in suppliers for 12 critical parts, to improve the parts' quality, productivity, and delivery. The common characteristic of all 12 parts is their electrical conductivity on specified surfaces, to allow electrical continuity for proper grounding of your device. The proposed changes do not involve any changes in the design or manufacturing process of the device.