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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 HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP040046
Date Received12/06/2004
Decision Date02/20/2013
Product Code FTR 
Docket Number 13M-0255
Notice Date 03/13/2013
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE NATRELLE® 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR WOMEN FOR THE FOLLOWING USES (PROCEDURES):1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD. 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; AND 2) BREAST RECONSTRUCTION. 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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S021 S022 S023 S024 S025 
S026 S027 S029 S030 S031 S032 
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