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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 SALINE-FILLED 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 NumberS003
Date Received03/28/2016
Decision Date11/17/2016
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for re-sterilization of the IDEAL IMPLANT® Saline-filled Breast Implant up to a total of 44 hours exposure time if the primary dry heat sterilization (DHS) cycle is interrupted and/or aborted
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