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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.
 
DeviceNatrelle Silicone-Filled Breast Implants
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP020056
Supplement NumberS045
Date Received10/02/2017
Decision Date11/03/2017
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implement an Electronic Data Acquisition (EDA) System to collect cycle parameter, such as temperature and time, for the shell drying after washing and gel curing after shell filling occur in the Blue-M oven. The above change is located 900 Parkway Global Park, La Aurora, Heredia, Costa Rica.
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