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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
ApplicantU-SYSTEMS, INC.
PMA NumberP110006
Supplement NumberS006
Date Received09/18/2015
Decision Date10/15/2015
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 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.