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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 NumberS005
Date Received03/19/2013
Decision Date04/17/2013
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 
Update in manufacturing process.
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