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 1) new style 2000 moderate plus profile, which is considered a modification to the existing product ine, with sizes 175cc-800cc; 2) additional sizes of 400cc, 450cc, 500cc, 600cc, 650cc and 800cc for style 1600; and 3) additional sizes of 350cc, 400cc, 700cc, 770cc, and 800cc for style 3000. There are no changes to the indications for use.
| Device | SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS |
| Classification Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Generic Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Applicant | MENTOR WORLDWIDE LLC |
| Date Received | 2005-06-27 |
| Decision Date | 2005-07-27 |
| PMA | P990075 |
| Supplement | S016 |
| 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 |