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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePuregraft Serene 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
Date Received06/25/2012
Decision Date11/14/2014
Product Code FWM 
Docket Number 14M-2042
Notice Date 11/25/2014
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00858052
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT. THIS DEVICE IS INDICATED FOR WOMEN AT LEAST 18 YEARS OLD UNDERGOING:1) PRIMARY BREAST AUGMENTATION TO INCREASE BREAST SIZE; AND 2) REVISION BREAST AUGMENTATION TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S015 S016 S017 S018 S020 S021 S022 S023 S024 S025 
S026 S027 
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