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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 Nameprosthesis, breast, inflatable, internal, saline
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
33 technology drive
irvine, CA 92618
PMA NumberP990075
Supplement NumberS024
Date Received07/31/2013
Decision Date08/20/2013
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add an additional sub-supplier of the connector system that is provided as an accessory with the devices.