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 labeling including modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (bia-alcl).
| Device | Mentor MemoryGel Breast Implants |
| Classification Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Generic Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Applicant | MENTOR CORP. |
| Date Received | 2017-11-06 |
| Decision Date | 2017-12-06 |
| PMA | P030053 |
| Supplement | S044 |
| Product Code | FTR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MENTOR CORP. 33 Technology Drive irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030053 | Original Filing | |
| S064 | 2021-06-25 | 30-day Notice |
| S063 | ||
| S062 | ||
| S061 | 2021-05-07 | 30-day Notice |
| S060 | 2021-05-07 | 30-day Notice |
| S059 | ||
| S058 | ||
| S057 | ||
| S056 | 2020-09-29 | Real-time Process |
| S055 | 2020-09-28 | 30-day Notice |
| S054 | 2019-10-23 | 30-day Notice |
| S053 | ||
| S052 | 2019-06-12 | 30-day Notice |
| S051 | ||
| S050 | ||
| S049 | ||
| S048 | ||
| S047 | 2018-05-29 | 30-day Notice |
| S046 | ||
| S045 | 2018-01-08 | 30-day Notice |
| S044 | 2017-11-06 | Special (immediate Track) |
| S043 | 2017-07-13 | Real-time Process |
| S042 | 2017-04-24 | 30-day Notice |
| S041 | 2017-03-27 | 30-day Notice |
| S040 | 2017-03-20 | 30-day Notice |
| S039 | 2017-03-14 | 30-day Notice |
| S038 | 2017-03-08 | 30-day Notice |
| S037 | 2017-02-14 | Real-time Process |
| S036 | 2016-11-22 | 135 Review Track For 30-day Notice |
| S035 | 2016-06-07 | 30-day Notice |
| S034 | 2016-05-27 | 30-day Notice |
| S033 | 2016-03-17 | 30-day Notice |
| S032 | 2015-10-21 | 30-day Notice |
| S031 | 2015-09-16 | Normal 180 Day Track No User Fee |
| S030 | 2015-08-26 | 30-day Notice |
| S029 | 2015-06-10 | 30-day Notice |
| S028 | 2015-04-08 | 30-day Notice |
| S027 | 2015-04-02 | 30-day Notice |
| S026 | 2015-03-19 | 30-day Notice |
| S025 | ||
| S024 | 2015-02-20 | 30-day Notice |
| S023 | 2014-12-16 | 30-day Notice |
| S022 | 2014-12-08 | 30-day Notice |
| S021 | 2014-11-25 | 30-day Notice |
| S020 | 2014-09-23 | 30-day Notice |
| S019 | 2014-08-04 | Normal 180 Day Track No User Fee |
| S018 | 2014-07-02 | 30-day Notice |
| S017 | 2014-02-19 | Normal 180 Day Track No User Fee |
| S016 | 2013-12-18 | Real-time Process |
| S015 | ||
| S014 | 2013-04-10 | Normal 180 Day Track No User Fee |
| S013 | 2013-01-25 | Real-time Process |
| S012 | 2011-02-11 | Normal 180 Day Track No User Fee |
| S011 | 2011-01-19 | Normal 180 Day Track No User Fee |
| S010 | ||
| S009 | 2010-07-16 | Normal 180 Day Track No User Fee |
| S008 | 2009-09-28 | Normal 180 Day Track No User Fee |
| S007 | ||
| S006 | 2008-04-29 | Normal 180 Day Track No User Fee |
| S005 | 2007-05-31 | Normal 180 Day Track |
| S004 | 2007-03-27 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2006-12-20 | Normal 180 Day Track |
| S001 | 2006-12-14 | Normal 180 Day Track No User Fee |