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 to implement an additional incoming specification, i. E. , verify the color of the gel material by using the ultra scan vis sensor system to confirm that the gel color does not change between shipment and receipt. There are no changes to existing incoming specification, manufacturing process, and final device specifications. The addition of this assessment is specific to the 900 parkway global park, la aurora, heredia, costa rica manufacturing site.
| Device | NATRELLE Silicon-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 | 2017-12-18 |
| Decision Date | 2018-06-27 |
| PMA | P020056 |
| Supplement | S046 |
| Product Code | FTR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 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 |
|---|---|---|
| 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 |