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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.
 
DeviceIDEAL IMPLANT Structured Breast Implant
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantBimini Health Tech
420 Stevens Ave.
Suite 220
Solana Beach, CA 92075
PMA NumberP120011
Supplement NumberS012
Date Received06/11/2018
Decision Date08/06/2018
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an extension of the shelf life for the fill tube assembly (FTA) from 3 years to 5 years
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