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 updated labeling to include the results of the 10 year clinical study.
| Device | MENTOR MEMORYSHAPE BREAST IMPLANTS |
| Classification Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Generic Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Applicant | MENTOR WORLDWIDE LLC |
| Date Received | 2016-02-11 |
| Decision Date | 2016-12-20 |
| PMA | P060028 |
| Supplement | S016 |
| Product Code | FTR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MENTOR WORLDWIDE LLC 33 Technology Drive irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060028 | Original Filing | |
| S044 | 2022-02-04 | Normal 180 Day Track No User Fee |
| S043 | 2021-06-25 | 30-day Notice |
| S042 | ||
| S041 | ||
| S040 | 2021-05-07 | 30-day Notice |
| S039 | 2021-05-07 | 30-day Notice |
| S038 | ||
| S037 | ||
| S036 | 2020-09-28 | 30-day Notice |
| S035 | ||
| S034 | 2019-10-23 | 30-day Notice |
| S033 | ||
| S032 | ||
| S031 | ||
| S030 | ||
| S029 | 2018-05-29 | 30-day Notice |
| S028 | ||
| S027 | 2017-11-06 | Special (immediate Track) |
| S026 | ||
| S025 | 2017-06-06 | Real-time Process |
| S024 | 2017-04-24 | 30-day Notice |
| S023 | 2017-03-27 | 30-day Notice |
| S022 | 2017-03-20 | 30-day Notice |
| S021 | 2017-03-14 | 30-day Notice |
| S020 | 2017-03-08 | 30-day Notice |
| S019 | 2016-11-22 | 135 Review Track For 30-day Notice |
| S018 | 2016-06-07 | 30-day Notice |
| S017 | ||
| S016 | 2016-02-11 | Normal 180 Day Track No User Fee |
| S015 | 2015-10-21 | 30-day Notice |
| S014 | 2015-09-30 | 135 Review Track For 30-day Notice |
| S013 | 2015-09-16 | Normal 180 Day Track No User Fee |
| S012 | 2015-06-10 | 30-day Notice |
| S011 | 2015-04-08 | 30-day Notice |
| S010 | 2015-04-02 | 30-day Notice |
| S009 | ||
| S008 | 2015-02-20 | 30-day Notice |
| S007 | 2015-02-20 | 30-day Notice |
| S006 | 2015-02-06 | 30-day Notice |
| S005 | 2014-12-22 | Normal 180 Day Track |
| S004 | 2014-12-08 | 30-day Notice |
| S003 | 2014-11-25 | 30-day Notice |
| S002 | 2014-09-23 | 30-day Notice |
| S001 | 2014-03-26 | Normal 180 Day Track |