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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.
 
DeviceMEMORYSHAPE BREAST IMPLANTS, CONTOUR PROFILE GEL 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 NumberS001
Date Received03/26/2014
Decision Date09/09/2014
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR FOUR ADDITIONAL MEMORYSHAPE¿ BREAST IMPLANT STYLES (MM+, MH, TM+ AND LM+).
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