This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.
| Device | Sientra OPUS Silicone Gel Breast Implants |
| Generic Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Applicant | SIENTRA, INC |
| Date Received | 2021-08-06 |
| Decision Date | 2021-10-27 |
| PMA | P070004 |
| Supplement | S033 |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIENTRA, INC 6769 Hollister Avenue suite 201 santa Barbara, CA 93117 |
| 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 |