LINX REFLUX MANAGEMENT SYSTEM

Implant, Anti-gastroesophageal Reflux

FDA Premarket Approval P100049

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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.

DeviceLINX REFLUX MANAGEMENT SYSTEM
Classification NameImplant, Anti-gastroesophageal Reflux
Generic NameImplant, Anti-gastroesophageal Reflux
ApplicantTORAX MEDICAL
Date Received2010-12-30
Decision Date2012-03-22
Notice Date2012-08-14
PMAP100049
SupplementS
Product CodeLEI
Docket Number12M-0893
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
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 NumberDateSupplement Type
P100049Original 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

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

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