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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLINX REFLUX MANAGEMENT SYSTEM
Classification Nameimplant, anti-gastroesophageal reflux
ApplicantTORAX MEDICAL
PMA NumberP100049
Supplement NumberS007
Date Received12/04/2013
Decision Date12/27/2013
Product Code
LEI[ Registered Establishments with LEI ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the firms cleaning machine, cleaning detergent, maximum bead load and cleaning temperature, and the addition of meshes during the cleaning and rinsing process.
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