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.
| Device | LINX Reflux Management System |
| Generic Name | Implant, Anti-gastroesophageal Reflux |
| Applicant | TORAX MEDICAL4188 Lexington Avenue Northshoreview, MN 55126 PMA NumberP100049 Supplement NumberS034 Date Received05/10/2022 Decision Date06/09/2022 Product Code LEI Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-10 |
| Decision Date | 2022-06-09 |
| PMA | P100049 |
| Supplement | S034 |
| 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 PMA NumberP100049 Supplement NumberS034 Date Received05/10/2022 Decision Date06/09/2022 Product Code LEI Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement qualification Of A New Components Supplier For The LINX Reflux Management System |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00855106005066 | P100049 | 000 |
| 00855106005011 | P100049 | 000 |
| 00855106005028 | P100049 | 000 |
| 00855106005035 | P100049 | 000 |
| 00855106005042 | P100049 | 000 |
| 00855106005059 | P100049 | 000 |
| 00855106005134 | P100049 | 003 |
| 00855106005165 | P100049 | 003 |
| 00855106005172 | P100049 | 003 |
| 00855106005189 | P100049 | 003 |
| 00855106005158 | P100049 | 003 |
| 00855106005141 | P100049 | 003 |
| 00855106005219 | P100049 | 004 |
| 00855106005226 | P100049 | 004 |
| 00855106005325 | P100049 | 011 |
| 00855106005332 | P100049 | 011 |
| 00855106005349 | P100049 | 011 |
| 00855106005356 | P100049 | 011 |
| 00855106005363 | P100049 | 011 |
| 00855106005370 | P100049 | 011 |