LINX Reflux Management System

FDA Premarket Approval P100049 S032

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.

Pre-market Approval Supplement Details

Changes regarding dcos 3872, 3893, 3876, 3753, 3792, and 3860

DeviceLINX Reflux Management System
Generic NameImplant, Anti-gastroesophageal Reflux
ApplicantTORAX MEDICAL
Date Received2021-12-10
Decision Date2022-01-07
PMAP100049
SupplementS032
Product CodeLEI 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address TORAX MEDICAL 4188 Lexington Avenue North shoreview, MN 55126

Supplemental Filings

Supplement NumberDateSupplement Type
P100049Original Filing
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

Device IDPMASupp
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

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.