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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received10/02/2006
Decision Date06/14/2013
Product Code FTR 
Docket Number 13M-0738
Notice Date 06/19/2013
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THEMEMORYSHAPE BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR FEMALES FOR THE FOLLOWING USES(PROCEDURES):1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD. BREAST AUGMENTATION INCLUDES PRIMARYBREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY. 2) BREAST RECONSTRUCTION. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACEBREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY. BREAST RECONSTRUCTION ALSO INCLUDES REVISIONSURGERY TO CORRECT OR IMPROVE THE RESULTS OF A PRIMARY BREAST RECONSTRUCTION SURGERY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S013 S018 S019 S034 S020 S021 S022 S023 S024 S025 S027 
S039 S040 S044 S056 S052 S029 S032 S033 S049 S050 S060 S002 
S012 S006 S007 S008 S003 S004 S010 S011 S014 S015 S005 S036 
S038 S041 S042 S043 S057 S058 S059 S001 S048 S054 S055 S051 
S016 S053 
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