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Device | SIENTRA SILICONE GEL BREAST IMPLANTS |
Generic Name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
Regulation Number | 878.3540 |
Applicant | Tiger Aesthetics Medical, LLC 9779 S. Franklin Dr., Suite 300 Franklin, WI 53132 |
PMA Number | P070004 |
Date Received | 01/22/2007 |
Decision Date | 03/09/2012 |
Product Code |
FTR |
Docket Number | 12M-0250 |
Notice Date | 03/09/2012 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S024 S025 S026 S027 S028 S029 S031 S033 S034 S035 S036 S037 S039 S040 S042 S043 S044 S046 |