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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 Implant
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantMentor Corp.
33 Technology Dr.
Irvin, CA 92618
PMA NumberP030053
Supplement NumberS088
Date Received04/03/2026
Decision Date04/30/2026
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  
Dimensional modification to the Small Outer Thermoform Tray mold to increase clearance between inner and outer trays by increasing from 0.031" to 0.050".
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