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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.
 
DeviceSIENTRA SILICONE GEL BREAST IMPLANTS
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantSIENTRA, INC
6769 HOLLISTER AVENUE
SUITE 201
SANTA BARBARA, CA 93117
PMA NumberP070004
Date Received01/22/2007
Decision Date03/09/2012
Product Code FTR 
Docket Number 12M-0250
Notice Date 03/09/2012
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE SIENTRA SILICONE GEL BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR: 1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD. BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF 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 RESULTS 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:  S001 S002 S003 S004 S007 S006 S008 S009 S010 S011 S019 
S017 S018 S035 S036 S033 S040 S012 S013 S014 S015 S016 S020 
S021 S022 S024 S025 S026 S027 S028 S029 S031 S034 S037 S042 
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