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 the diphenyl patch design. The device, as modified, will be marketed under the trade name natrelle silicone-filled breast implants and is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
| 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 | 2007-02-23 |
| Decision Date | 2007-05-02 |
| PMA | P020056 |
| Supplement | S002 |
| Product Code | FTR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |