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 bioburden testing method and samples used for testing.
| Device | NATRELLE HIGHLY COHESIVE 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 | 2014-09-29 |
| Decision Date | 2014-10-29 |
| PMA | P040046 |
| Supplement | S011 |
| 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 |