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 adding a new mixing specification of ± 2. 5 % (by weight) for theplatinum silicone catalyst (part a) and cross-linked siloxane (part b) weights, noting that weights vary based on the size of the production run to produce the standard dispersion (p/n 200-003) and the barrier dispersion (p/n 200-004) during the production of breast implant shells.
| Device | NATRELLE SILICONE-FILLED BREAST IMPLANTS |
| Classification Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Generic Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Applicant | Allergan |
| Date Received | 2016-09-07 |
| Decision Date | 2016-10-07 |
| PMA | P020056 |
| Supplement | S035 |
| Product Code | FTR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Allergan 2525 Dupont Dr. irvine, CA 92612 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020056 | Original Filing | |
| S059 | 2022-04-04 | Real-time Process |
| S058 | 2022-04-01 | 135 Review Track For 30-day Notice |
| S057 | 2021-06-30 | 30-day Notice |
| S056 | 2021-06-21 | 30-day Notice |
| S055 | 2021-05-26 | 30-day Notice |
| S054 | ||
| S053 | 2021-03-12 | 30-day Notice |
| S052 | ||
| S051 | 2020-06-30 | 30-day Notice |
| S050 | ||
| S049 | 2019-06-06 | 30-day Notice |
| S048 | 2018-07-02 | 30-day Notice |
| S047 | ||
| S046 | 2017-12-18 | 135 Review Track For 30-day Notice |
| S045 | 2017-10-02 | 30-day Notice |
| S044 | 2017-07-20 | 30-day Notice |
| S043 | 2017-07-03 | 30-day Notice |
| S042 | 2017-06-07 | 30-day Notice |
| S041 | 2017-04-13 | 135 Review Track For 30-day Notice |
| S040 | 2017-03-01 | Normal 180 Day Track |
| S039 | ||
| S038 | 2016-11-23 | Real-time Process |
| S037 | 2016-11-07 | 30-day Notice |
| S036 | 2016-09-30 | Real-time Process |
| S035 | 2016-09-07 | Special (immediate Track) |
| S034 | 2016-06-27 | Real-time Process |
| S033 | 2016-05-17 | 30-day Notice |
| S032 | 2015-12-30 | Normal 180 Day Track No User Fee |
| S031 | 2014-12-05 | Normal 180 Day Track |
| S030 | ||
| S029 | 2014-10-15 | Normal 180 Day Track No User Fee |
| S028 | 2014-09-29 | 30-day Notice |
| S027 | 2014-09-15 | Normal 180 Day Track |
| S026 | 2014-08-29 | Normal 180 Day Track |
| S025 | 2014-05-30 | Normal 180 Day Track No User Fee |
| S024 | 2014-01-17 | 30-day Notice |
| S023 | 2013-10-08 | Normal 180 Day Track No User Fee |
| S022 | 2013-06-12 | 30-day Notice |
| S021 | 2013-05-21 | 30-day Notice |
| S020 | 2013-05-20 | 30-day Notice |
| S019 | 2013-02-26 | 30-day Notice |
| S018 | 2012-12-31 | Normal 180 Day Track No User Fee |
| S017 | 2012-05-29 | 30-day Notice |
| S016 | 2012-01-25 | Normal 180 Day Track No User Fee |
| S015 | ||
| S014 | ||
| S013 | 2011-01-14 | 30-day Notice |
| S012 | ||
| S011 | 2009-10-13 | 30-day Notice |
| S010 | 2009-01-30 | 30-day Notice |
| S009 | 2008-08-18 | Normal 180 Day Track No User Fee |
| S008 | 2008-08-18 | Normal 180 Day Track No User Fee |
| S007 | 2008-08-13 | 30-day Notice |
| S006 | 2008-03-19 | Normal 180 Day Track No User Fee |
| S005 | 2008-03-12 | 30-day Notice |
| S004 | 2007-08-29 | Normal 180 Day Track No User Fee |
| S003 | 2007-02-26 | Normal 180 Day Track No User Fee |
| S002 | 2007-02-23 | Normal 180 Day Track |
| S001 | 2007-01-31 | Normal 180 Day Track No User Fee |