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.
Use of previously approved semi-automated primary packaging equipment spps following relocation from the main assembly controlled manufacturing environment cme room to the primary packaging cme room at the mentor irving, texas facility.
Device | MENTOR 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 | 2016-06-07 |
Decision Date | 2016-07-05 |
PMA | P030053 |
Supplement | S035 |
Product Code | FTR |
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 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 |