Changes regarding dcos 3872, 3893, 3876, 3753, 3792, and 3860
| Device | LINX Reflux Management System |
| Generic Name | Implant, Anti-gastroesophageal Reflux |
| Applicant | TORAX MEDICAL |
| Date Received | 2021-12-10 |
| Decision Date | 2022-01-07 |
| PMA | P100049 |
| Supplement | S032 |
| Product Code | LEI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TORAX MEDICAL 4188 Lexington Avenue North shoreview, MN 55126 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100049 | | Original Filing |
| S034 |
2022-05-10 |
30-day Notice |
| S033 | | |
| S032 |
2021-12-10 |
30-day Notice |
| S031 |
2021-12-10 |
30-day Notice |
| S030 |
2021-12-10 |
30-day Notice |
| S029 | | |
| S028 |
2019-10-25 |
30-day Notice |
| S027 | | |
| S026 |
2019-06-28 |
30-day Notice |
| S025 |
2018-10-31 |
30-day Notice |
| S024 |
2018-09-19 |
30-day Notice |
| S023 |
2018-08-22 |
30-day Notice |
| S022 |
2018-07-02 |
30-day Notice |
| S021 |
2017-12-21 |
Normal 180 Day Track |
| S020 |
2017-11-15 |
Normal 180 Day Track No User Fee |
| S019 |
2016-12-15 |
30-day Notice |
| S018 |
2016-09-29 |
30-day Notice |
| S017 |
2016-04-29 |
30-day Notice |
| S016 |
2016-02-08 |
30-day Notice |
| S015 |
2015-12-08 |
Normal 180 Day Track |
| S014 |
2015-06-25 |
30-day Notice |
| S013 |
2015-06-23 |
30-day Notice |
| S012 |
2015-03-25 |
30-day Notice |
| S011 |
2014-10-27 |
Normal 180 Day Track |
| S010 |
2014-06-23 |
Special (immediate Track) |
| S009 |
2014-05-15 |
30-day Notice |
| S008 |
2014-03-12 |
30-day Notice |
| S007 |
2013-12-04 |
30-day Notice |
| S006 |
2013-05-07 |
Real-time Process |
| S005 |
2013-03-19 |
30-day Notice |
| S004 |
2012-06-19 |
Normal 180 Day Track |
| S003 |
2012-06-19 |
Normal 180 Day Track |
| S002 |
2012-04-23 |
Normal 180 Day Track No User Fee |
| S001 |
2012-04-23 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices