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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
PMA NumberP120011
Date Received06/25/2012
Decision Date11/14/2014
Product Code
FWM[ Registered Establishments with 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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001