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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 NumberS013
Date Received07/25/2018
Decision Date08/22/2018
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Replace the current 100% shell inspection for thickness with a zero acceptance number (c=0, AQL=1.0%) shell sampling plan for thickness at the Vesta Intermediate Funding Inc located at 9900 S 57th Street, Franklin, Wisconsin.
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