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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
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
Supplement NumberS016
Date Received02/11/2016
Decision Date12/20/2016
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updated labeling to include the results of the 10 year clinical study.
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