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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.
Classification Nameautomated breast ultrasound
PMA NumberP110006
Supplement NumberS003
Date Received02/26/2014
Decision Date03/20/2014
Product Code
PAA[ Registered Establishments with PAA ]
Advisory Committee Radiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product 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.