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. |
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Device | LINX REFLUX MANAGEMENT SYSTEM |
Generic Name | IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX |
Applicant | TORAX MEDICAL 4545 Creek Rd Cincinnati, OH 45242 |
PMA Number | P100049 |
Supplement Number | S010 |
Date Received | 06/23/2014 |
Decision Date | 07/22/2014 |
Product Code |
LEI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING ALTERATIONS INCLUDING ADVERSE EVENT INFORMATION ABOUT EROSION OF THE LINX DEVICE, CLARIFICATIONS OR CONTRAINDICATIONS REGARDING NICKEL, WARNINGS REGARDING STORAGE AND USE ABOVE 60 DEGREES C, ADDITIONAL POTENTIAL RISK OF SALIVA/MUCUS BUILD-UP, AND DIRECTIONS WHICH ADD THE REMOVAL OF SUTURES AFTER THE CLASP ENDS ARE FULLY ENGAGED. |
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