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.
Change of supplier for molded silicone components to porges, division of mentor, sarlat sedex, france and a change in supplier of the raw material from dow corning to nusil for one molded component.
| Device | MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES |
| Classification Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Generic Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Applicant | MENTOR WORLDWIDE LLC |
| Date Received | 2002-05-10 |
| Decision Date | 2002-06-07 |
| PMA | P990075 |
| Supplement | S008 |
| Product Code | FWM |
| 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 |
|---|---|---|
| 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 |