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.
Standardizing the frequency of filtering and replacing isopropyl alcohol (ipa) in the manufacturing of sientra® opus silicone gel breast implants.
| Device | Sientra OPUS 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 | 2019-09-30 |
| Decision Date | 2019-10-29 |
| PMA | P070004 |
| Supplement | S021 |
| Product Code | FTR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIENTRA, INC 6769 Hollister Avenue suite 201 santa Barbara, CA 93117 |
| 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 |