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.
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.
| Device | SIENTRA SILICONE GEL BREAST IMPLANTS |
| Classification Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Generic Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Applicant | SIENTRA, INC |
| Date Received | 2007-01-22 |
| Decision Date | 2012-03-09 |
| Notice Date | 2012-03-09 |
| PMA | P070004 |
| Supplement | S |
| Product Code | FTR |
| Docket Number | 12M-0250 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIENTRA, INC 6769 Hollister Avenue suite 201 santa Barbara, CA 93117 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070004 | Original Filing | |
| S037 | 2022-06-17 | 30-day Notice |
| S036 | ||
| S035 | 2022-04-08 | Real-time Process |
| S034 | 2022-01-31 | 30-day Notice |
| S033 | 2021-08-06 | Normal 180 Day Track |
| S032 | ||
| S031 | 2020-03-04 | 30-day Notice |
| S030 | ||
| S029 | ||
| S028 | 2019-10-22 | 30-day Notice |
| S027 | ||
| S026 | 2019-10-07 | 30-day Notice |
| S025 | 2019-10-03 | 30-day Notice |
| S024 | 2019-10-03 | 30-day Notice |
| S023 | ||
| S022 | 2019-09-30 | 30-day Notice |
| S021 | 2019-09-30 | 30-day Notice |
| S020 | 2019-09-16 | 30-day Notice |
| S019 | ||
| S018 | ||
| S017 | ||
| S016 | ||
| S015 | 2019-01-07 | Real-time Process |
| S014 | 2017-12-21 | 30-day Notice |
| S013 | 2017-12-14 | 135 Review Track For 30-day Notice |
| S012 | 2017-12-11 | 30-day Notice |
| S011 | 2017-11-06 | Special (immediate Track) |
| S010 | 2017-06-05 | Normal 180 Day Track No User Fee |
| S009 | 2017-03-15 | Normal 180 Day Track No User Fee |
| S008 | 2015-03-23 | Real-time Process |
| S007 | 2013-12-12 | 30-day Notice |
| S006 | 2013-09-19 | Real-time Process |
| S005 | ||
| S004 | 2012-04-09 | Normal 180 Day Track No User Fee |
| S003 | 2012-03-30 | Normal 180 Day Track No User Fee |
| S002 | 2012-03-30 | Normal 180 Day Track No User Fee |
| S001 | 2012-03-30 | Normal 180 Day Track No User Fee |