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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 NumberS013
Date Received06/23/2015
Decision Date07/20/2015
Product Code LEI 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
IMPLEMENTATION OF AN UPGRADED MEASUREMENT SYSTEM TO FACILITATE RECEIVING/INSPECTION AND VARIOUS R&D PROJECTS.
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