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.
Addition of a variable frequency drive (vfd) to the dipping hood blower system used 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 | S022 |
| 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 |