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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.
 
DeviceMENTOR™ MemoryGel™ Enhance Breast Implants
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantMentor Corp.
33 Technology Dr.
Irvin, CA 92618
PMA NumberP030053
Supplement NumberS083
Date Received08/07/2025
Decision Date05/11/2026
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the for revisions to the Statistical Analysis Plan (SAP) for the post-approval study (PAS) referenced above. The SAP revision has been submitted to comply with the conditions of approval outlined in our approval order for P030053/S069.
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