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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.
 
DeviceMemoryGel Silicone Gel-Filled Breast Implants
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantMentor Corp.
33 Technology Dr.
Irvin, CA 92618
PMA NumberP030053
Supplement NumberS052
Date Received06/12/2019
Decision Date07/12/2019
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Reconfiguration of the MemoryGel® Silicone Gel-Filled Breast Implant shell assembly and laser marking process steps from a batch process to a single piece flow manufacturing line. The change is applicable to the steps after the shells have been manufactured but before they are filled with gel and cured. The batch to single piece flow manufacturing process change is specific to the smooth shell surface version of the implants and is not applicable to the textured shell implant versions.
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