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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.
 
DevicePuregraft Serene Breast Implant, IDEAL 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 NumberS028
Date Received08/16/2024
Decision Date02/11/2025
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to update the Instructions for Use and the Patient Information Booklet that were previously reviewed under P120011/S025
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