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 additional natrelle 410 device styles and sizes including: one (1) size of style fl 410; one (1) size of style ml 410; two (2) sizes of style ll 410; four (4) sizes of style lm 410; ten (10) sizes of style lf 410; nine (9) sizes of style fx 410; nine (9) sizes of style mx 410; and seven (7) sizes of style lx 410.
| Device | NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED 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 | 2014-08-11 |
| Decision Date | 2014-11-07 |
| PMA | P040046 |
| Supplement | S008 |
| Product Code | FTR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| 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 |
|---|---|---|
| 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 |