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.
Changes to add a new clean manufacturing environment (cme) room for the storage of device component shells. The breast implants are manufactured at mentor's irving, texas facility.
| 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 | 2015-06-10 |
| Decision Date | 2015-07-01 |
| PMA | P060028 |
| Supplement | S012 |
| 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 | 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 |