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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
33 Technology Drive
Irvine, CA 92618
PMA NumberP060028
Supplement NumberS014
Date Received09/30/2015
Decision Date02/05/2016
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for 1) change 100291296: Update packaging processes with Alloyd Heat Sealers and Tyvek Pouch to implement the use of the Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices; and 2) change 100248737: minor layout modifications to the gel fill area were made to increase operational efficiency.