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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 MemoryShape Breast Implants
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantMentor Worldwide, LLC
33 Technology Dr.
Irvin, CA 92618
PMA NumberP060028
Supplement NumberS039
Date Received05/07/2021
Decision Date06/04/2021
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes in the primary packaging equipment used in the manufacturing process for MemoryShape, MemoryGel, and Saline-Filled andSpectrum Breast Implants
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