Approval for labeling alterations including adverse event information about erosion of the linx device, clarifications or contraindications regarding nickel, warnings regarding storage and use above 60 degrees c, additional potential risk of saliva/mucus build-up, and directions which add the removal of sutures after the clasp ends are fully engaged.
| Device | LINX REFLUX MANAGEMENT SYSTEM |
| Generic Name | Implant, Anti-gastroesophageal Reflux |
| Applicant | TORAX MEDICAL |
| Date Received | 2014-06-23 |
| Decision Date | 2014-07-22 |
| PMA | P100049 |
| Supplement | S010 |
| Product Code | LEI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| 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