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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, inflatable, internal, saline
Regulation Number878.3530
IRVINE, CA 92612
PMA NumberP990074
Supplement NumberS033
Date Received09/07/2016
Decision Date10/07/2016
Product Code FWM 
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.