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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceLINX REFLUX MANAGEMENT SYSTEM
Generic NameIMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
ApplicantTORAX MEDICAL
4545 Creek Rd
Cincinnati, OH 45242
PMA NumberP100049
Date Received12/30/2010
Decision Date03/22/2012
Product Code LEI 
Docket Number 12M-0893
Notice Date 08/14/2012
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT00776997
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S018 S017 S016 S001 S002 S003 S004 S008 S009 S010 S011 S012 
S013 S014 S015  S005 S006 S007 S019 S023 S027 S028 S021 
S020 S024 S022 S026 S025 S034 S033 S030 S031 S032 S029 S035 
S036 S037 
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