Approval for modifications to the internal magnets and wire links connecting the beads, as well as associated modifications to the labeling, allowing the device to be magnetic resonance (mr) conditional up to 1. 5 tesla.
| Device | LINX REFLUX MANAGEMENT SYSTEM |
| Classification Name | Implant, Anti-gastroesophageal Reflux |
| Generic Name | Implant, Anti-gastroesophageal Reflux |
| Applicant | TORAX MEDICAL |
| Date Received | 2014-10-27 |
| Decision Date | 2015-01-21 |
| PMA | P100049 |
| Supplement | S011 |
| Product Code | LEI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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