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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 Saline-Filled Breast Implants
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP020056
Supplement NumberS055
Date Received05/26/2021
Decision Date06/25/2021
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Change to implement an Electronic Data Acquisition (EDA) System to record and store the cycle parameters of the dry heat sterilization process used in the manufacture of Allergan Natrelle® Saline-Filled Breast Implants and Allergan Natrelle® Silicone-Filled Breast Implants
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