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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
Classification Nameimplant, anti-gastroesophageal reflux
Generic Nameimplant, anti-gastroesophageal reflux
Applicant
TORAX MEDICAL
4188 lexington avenue north
shoreview, MN 55126
PMA NumberP100049
Date Received12/30/2010
Decision Date03/22/2012
Product Code
LEI[ Registered Establishments with LEI ]
Docket Number 12M-0893
Notice Date 08/14/2012
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT00776997
NCT01058070
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 
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