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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
ApplicantBimini Health Tech
420 Stevens Ave. Suite 220
Solana Beach, CA 92075
PMA NumberP120011
Supplement NumberS005
Date Received04/15/2016
Decision Date05/13/2016
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Manufacturing sequence change: baffle shell slitting process was moved to follow the 2-inch hole die-cutting step, instead of preceding it. The facility is located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, CA 92780.