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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.
 
DeviceIDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
Applicant
IDEALIMPLANT
5005 lbj freeway suite 900
dallas,, TX 75244
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
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 StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
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