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.
Electronic data acquisition system (eda) instead of via a chart recorder.
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 | 2013-06-12 |
Decision Date | 2013-07-10 |
PMA | P040046 |
Supplement | S004 |
Product Code | FTR |
Advisory Committee | General & Plastic Surgery |
Supplement Type | 30-day Notice |
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 |