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.
Change in the method for bioburden monitoring.
| Device | NATRELLE HIGHLY COHESIVE ANATOMICALLY 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 | 2016-11-07 |
| Decision Date | 2016-12-07 |
| PMA | P040046 |
| Supplement | S018 |
| 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 | Allergan 2525 Dupont Dr. irvine, CA 92612 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040046 | Original Filing | |
| S032 | 2020-06-30 | 30-day Notice |
| S031 | ||
| S030 | 2019-06-06 | 30-day Notice |
| S029 | 2018-07-02 | 30-day Notice |
| S028 | ||
| S027 | 2017-12-18 | 135 Review Track For 30-day Notice |
| S026 | 2017-10-02 | 30-day Notice |
| S025 | 2017-07-20 | 30-day Notice |
| S024 | 2017-07-03 | 30-day Notice |
| S023 | 2017-06-07 | 30-day Notice |
| S022 | 2017-04-13 | 135 Review Track For 30-day Notice |
| S021 | 2017-03-01 | Normal 180 Day Track |
| S020 | ||
| S019 | 2016-11-23 | Real-time Process |
| S018 | 2016-11-07 | 30-day Notice |
| S017 | 2016-09-07 | Special (immediate Track) |
| S016 | 2016-05-24 | Real-time Process |
| S015 | 2016-05-17 | 30-day Notice |
| S014 | 2015-12-30 | Normal 180 Day Track No User Fee |
| S013 | 2014-12-30 | Normal 180 Day Track |
| S012 | 2014-10-16 | Normal 180 Day Track No User Fee |
| S011 | 2014-09-29 | 30-day Notice |
| S010 | ||
| S009 | 2014-09-15 | Normal 180 Day Track |
| S008 | 2014-08-11 | Real-time Process |
| S007 | 2014-05-30 | Normal 180 Day Track No User Fee |
| S006 | 2014-01-17 | 30-day Notice |
| S005 | 2014-01-02 | Normal 180 Day Track No User Fee |
| S004 | 2013-06-12 | 30-day Notice |
| S003 | 2013-05-22 | 30-day Notice |
| S002 | 2013-05-20 | 30-day Notice |
| S001 | 2013-02-26 | 30-day Notice |