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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
IRVINE, CA 92612
PMA NumberP020056
Supplement NumberS032
Date Received12/30/2015
Decision Date08/25/2016
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for removal of the DSMB from the BIFS-001 study protocol.