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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.
 
DeviceMotiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantMotiva USA, LLC
2543 Mesa School Ln.
Santa Barbara, CA 93109
PMA NumberP230005
Supplement NumberS005
Date Received04/02/2026
Decision Date09/25/2026
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
adding an additional supplier for the shell patch and patch filler components
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