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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameMENTOR MEMORYSHAPE BREAST IMPLANTS
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantMENTOR CORP.
PMA NumberP060028
Date Received10/06/2006
Decision Date06/14/2013
Product Code
FTR[ Registered Establishments with FTR ]
Docket Number 13M-0738
Notice Date 06/19/2013
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the memoryshape 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 primary breast 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 replace breast 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 revision surgery to correct or improve the results of a primary breast reconstruction surgery.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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