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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 NumberS007
Date Received09/21/2016
Decision Date10/20/2016
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  
Extra valve competence testing on valves prior to assembly into implants, implemented during commercial production start-up, will be discontinued; andthe extra valve competence testing on valves in finished (i.e., packaged and sterilized) implants during commercial production start-up, will be discontinued. However, valve competence testing on valves in finished implants will continue to meet the requirements of the AQL sampling specified in Ideal Implant’s Finished Product Specification FP 001.