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 implementation of a co2 shell soaking process as an alternative to the current isopropyl alcohol (ipa) shell soaking process for removal of primarily low molecular weight (lmw) siloxanes from high temperature vulcanized (htv) round and shaped breast implant shells.
| Device | 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 | 2016-11-22 |
| Decision Date | 2017-05-08 |
| PMA | P030053 |
| Supplement | S036 |
| Product Code | FTR |
| 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 | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |