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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLINX Reflux Management System
Generic NameIMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
ApplicantTorax Medical
4545 Creek Rd.
Cincinnati, OH 45242
PMA NumberP100049
Supplement NumberS033
Date Received04/08/2022
Decision Date10/04/2022
Product Code LEI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following labeling updates: 1) inclusion of final post-approval study results; 2) addition of a precaution based on RELIEF study results; 3) addition of “swallow-induced syncope to the list of adverse events; and 4) revised registered/trademark status.
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