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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 NumberS003
Date Received06/19/2012
Decision Date01/24/2013
Product Code
LEI[ Registered Establishments with LEI ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design change that incorporates a clasp into the linx device.
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