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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 NumberS010
Date Received10/23/2017
Decision Date11/17/2017
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the labeling including modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
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