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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
Generic Namesilicone gel-filled breast implant
Regulation Number878.3540
PMA NumberP030053
Supplement NumberS016
Date Received12/18/2013
Decision Date03/18/2014
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
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.