Premarket Approval (PMA)

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.

• Device: Puregraft Serene Breast Implant
• Generic Name: Prosthesis, breast, inflatable, internal, saline
• Regulation Number: 878.3530
• Applicant: Bimini Health Tech; 420 Stevens Ave.; Suite 220; Solana Beach, CA 92075
• PMA Number: P120011
• Date Received: 06/25/2012
• Decision Date: 11/14/2014
• Product Code: FWM
• Docket Number: 14M-2042
• Notice Date: 11/25/2014
• Advisory Committee: General & Plastic Surgery
• Clinical Trials: NCT00858052
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH 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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S002 S004 S005 S008 S006 S001 S003 S007 S010 S011 S017 ; S015 S016 S025 S022 S028 S009 S012 S013 S021 S020 S018 S026 ; S027 S024 S023