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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceMENTOR MEMORYSHAPE BREAST IMPLANTS
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
Applicant
MENTOR WORLDWIDE LLC
33 technology drive
irvine, CA 92618
PMA NumberP060028
Date Received10/02/2006
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
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S018 
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