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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.
 
DeviceNATRELLE SILICONE-FILLED BREAST IMPLANTS
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP020056
Date Received12/30/2002
Decision Date11/17/2006
Product Code FTR 
Docket Number 06M-0490
Notice Date 11/17/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE INAMED SILICONE-FILLED BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD AND FOR BREAST RECONSTRUCTION FOR WOMEN OF ANY AGE. BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY. BREAST RECONSTRUCTION ALSO INCLUDES REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST RECONSTRUCTION SURGERY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S013 S033 S024 S017 S026 S007 S008 S009 S004 S032 S038 
S041 S018 S027 S028 S025 S020 S021 S023 S029 S031 S016 S019 
S005 S006 S010 S011 S001 S002 S003 S036 S043 S034 S040 S037 
S035 S042 S022 S048 S049 S055 S056 S057 S053 S054 S044 S046 
S045 S051 S061 S058 S059 
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