Approval for the linx reflux management system. This device is indicated for patients diagnosed with gastroesophageal reflux disease (gerd) as defined by abnormal ph testing, and who continue to have chronic gerd symptoms despite maximum therapy for the treatment of reflux.
| Device | LINX REFLUX MANAGEMENT SYSTEM |
| Classification Name | Implant, Anti-gastroesophageal Reflux |
| Generic Name | Implant, Anti-gastroesophageal Reflux |
| Applicant | TORAX MEDICAL |
| Date Received | 2010-12-30 |
| Decision Date | 2012-03-22 |
| Notice Date | 2012-08-14 |
| PMA | P100049 |
| Supplement | S |
| Product Code | LEI |
| Docket Number | 12M-0893 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TORAX MEDICAL 4188 Lexington Avenue North shoreview, MN 55126 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
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