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 modifications to the winged infusion set accessory of the mentor saline-filled and spectrum breast implant. The modifications included: 1. Texture, beveled edges, and a finger hole was added to each (2) side of the wing design; 2. Phthalate was eliminated from the wing material: pvc nakan fem 828 n n with dehp with colorant masterbatch pvc 9154 green to pvc nakan fem 828 n n with deht with colorant masterbatch pvc 9154 green; and3. Phthalate was eliminated from the tubing material: pvc nakan fma 748 n n with dehp to pvc nakan fma 748 n n with deht.
| Device | MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT |
| Classification Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Generic Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Applicant | MENTOR WORLDWIDE LLC |
| Date Received | 2014-10-27 |
| Decision Date | 2014-11-26 |
| PMA | P990075 |
| Supplement | S029 |
| Product Code | FWM |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MENTOR WORLDWIDE LLC 33 Technology Drive irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990075 | Original Filing | |
| S054 | 2022-05-10 | 135 Review Track For 30-day Notice |
| S053 | ||
| S052 | 2021-06-25 | 30-day Notice |
| S051 | ||
| S050 | 2021-05-07 | 30-day Notice |
| S049 | 2020-10-30 | 30-day Notice |
| S048 | 2020-09-30 | 30-day Notice |
| S047 | 2020-09-28 | 30-day Notice |
| S046 | 2019-10-23 | 30-day Notice |
| S045 | 2019-06-25 | 30-day Notice |
| S044 | 2018-05-29 | 30-day Notice |
| S043 | 2017-11-06 | Special (immediate Track) |
| S042 | 2017-07-12 | 30-day Notice |
| S041 | 2017-04-24 | 30-day Notice |
| S040 | 2017-03-27 | 30-day Notice |
| S039 | 2017-03-14 | 30-day Notice |
| S038 | 2017-03-08 | 30-day Notice |
| S037 | 2016-06-07 | 30-day Notice |
| S036 | 2016-03-17 | 30-day Notice |
| S035 | 2015-12-11 | 30-day Notice |
| S034 | 2015-10-21 | 30-day Notice |
| S033 | 2015-06-10 | 30-day Notice |
| S032 | 2015-04-02 | 30-day Notice |
| S031 | 2014-12-08 | 30-day Notice |
| S030 | 2014-11-25 | 30-day Notice |
| S029 | 2014-10-27 | Real-time Process |
| S028 | 2014-10-22 | 30-day Notice |
| S027 | 2014-09-23 | 30-day Notice |
| S026 | 2014-07-15 | 30-day Notice |
| S025 | 2014-01-22 | 30-day Notice |
| S024 | 2013-07-31 | 30-day Notice |
| S023 | 2013-05-01 | 30-day Notice |
| S022 | 2011-02-11 | Normal 180 Day Track No User Fee |
| S021 | 2008-04-02 | Normal 180 Day Track No User Fee |
| S020 | ||
| S019 | 2008-01-24 | Normal 180 Day Track |
| S018 | ||
| S017 | 2007-03-01 | 30-day Notice |
| S016 | 2005-06-27 | Real-time Process |
| S015 | 2004-08-24 | Normal 180 Day Track |
| S014 | 2003-11-20 | Normal 180 Day Track No User Fee |
| S013 | 2003-08-01 | 30-day Notice |
| S012 | 2003-07-16 | 30-day Notice |
| S011 | 2003-02-24 | 30-day Notice |
| S010 | 2003-02-07 | 30-day Notice |
| S009 | 2002-07-01 | Normal 180 Day Track |
| S008 | 2002-05-10 | 30-day Notice |
| S007 | 2002-03-26 | 30-day Notice |
| S006 | 2001-07-26 | Normal 180 Day Track |
| S005 | 2001-07-09 | Normal 180 Day Track |
| S004 | 2001-07-10 | Normal 180 Day Track |
| S003 | 2001-05-14 | Normal 180 Day Track |
| S002 | 2000-10-23 | Normal 180 Day Track |
| S001 | 2000-06-08 | Normal 180 Day Track |