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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 NumberS015
Date Received12/08/2015
Decision Date03/02/2016
Product Code LEI 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT00776997
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updating the labeling with safety and effectiveness data out to five (5) years for the pivotal trial cohort extended follow-up that has been completed and modify the Indications For Use.
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