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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.
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
PMA NumberP060028
Supplement NumberS012
Date Received06/10/2015
Decision Date07/01/2015
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 
Changes to add a new clean manufacturing environment (cme) room for the storage of device component shells. The breast implants are manufactured at mentor's irving, texas facility.