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.
Addition of an automated lot verification process prior to primary packaging and expansion of the primary packaging room configuration.
| Device | Mentor Saline-Filled and SPECTRUM Breast Implants |
| Classification Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Generic Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Applicant | MENTOR WORLDWIDE LLC |
| Date Received | 2018-05-29 |
| Decision Date | 2018-06-26 |
| PMA | P990075 |
| Supplement | S044 |
| Product Code | FWM |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |