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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 NumberS011
Date Received10/27/2014
Decision Date01/21/2015
Product Code LEI 
Advisory Committee Gastroenterology/Urology
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 MODIFICATIONS TO THE INTERNAL MAGNETS AND WIRE LINKS CONNECTING THE BEADS, AS WELL AS ASSOCIATED MODIFICATIONS TO THE LABELING, ALLOWING THE DEVICE TO BE MAGNETIC RESONANCE (MR) CONDITIONAL UP TO 1.5 TESLA.
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