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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.
Generic Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
33 technology drive
irvine, CA 92618
PMA NumberP030053
Supplement NumberS016
Date Received12/18/2013
Decision Date03/18/2014
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THIRTY-ONE STYLES INCLUDING SIXTEEN SMOOTH ROUND ULTRA HIGH PROFILE DEVICES: 350-5135BC, 350-5160BC, 350-5180BC, 350-5215BC, 350-5240BC, 350-5270BC, 350-5295BC, 350-5320BC, 350-5350BC, 350-5375BC, 350-5400BC, 350-5430BC, 350-5455BC, 350-5480BC, 350-5535BC, AND 350-5590BC; AND FIFTEEN SILTEX® ROUND ULTRA HIGH PROFILE DEVICES: 354-5135, 354-5160, 354-5185, 354-5215, 354-5240, 354-5270, 354-5295, 354-5320, 354-5350, 354-5375, 354-5400, 354-5430, 354-5455, 354-5480, AND 354-5535.