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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 NumberS015
Date Received05/21/2019
Decision Date09/19/2019
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
Approval Order Statement  
Approval for a change to the manufacturing tooling and heighten quality control for patch component #7 inside diameter.
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