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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Namesilicone gel-filled breast implant
Regulation Number878.3540
ApplicantMENTOR WORLDWIDE LLC
PMA NumberP030053
Supplement NumberS024
Date Received02/20/2015
Decision Date03/17/2015
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to automate the gel mix material sampling process to be used in the production of memoryshape, and memorygel silicone gel-filled breast implants manufactured at mentor's irving, texas facility.
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