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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameLINX REFLUX MANAGEMENT SYSTEM
Classification Nameimplant, anti-gastroesophageal reflux
ApplicantTORAX MEDICAL
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 
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