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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 NumberS019
Date Received12/15/2016
Decision Date01/12/2017
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  
Utilization of an additional, higher capacity laser welding system and to maintain 100% individual link length inspection conducted at final device inspection, but remove all in-process assembly weld link length inspections and the overall device length final inspection.
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