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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 REGLUX MANAGEMENT SYSTEM
Classification Nameimplant, anti-gastroesophageal reflux
ApplicantTORAX MEDICAL
PMA NumberP100049
Supplement NumberS008
Date Received03/13/2014
Decision Date04/09/2014
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 
Change to the diameter for the weld balls that are at the end of the links that connect the individual linx device beads.
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