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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 NumberS008
Date Received02/20/2015
Decision Date03/19/2015
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 PRODUCTION OF MEMORYSHAPE BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY. THE CHANGES INCLUDE EXPANDING THE GOWNING AREA, INCREASING THE NUMBER OF DRYING RODS IN THE SHELL DRYING OVEN AND UPDATING THE BOWL FILL PROCEDURE.
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