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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 NumberS035
Date Received09/07/2016
Decision Date10/07/2016
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for adding a new mixing specification of ± 2.5 % (by weight) for theplatinum silicone catalyst (Part A) and cross-linked siloxane (Part B) weights, noting that weights vary based on the size of the production run to produce the standard dispersion (P/N 200-003) and the barrier dispersion (P/N 200-004) during the production of breast implant shells.