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, IMPLANT AND SIZING TOOL |
Generic Name | IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX |
Applicant | TORAX MEDICAL 4545 Creek Rd Cincinnati, OH 45242 |
PMA Number | P100049 |
Supplement Number | S018 |
Date Received | 09/29/2016 |
Decision Date | 10/20/2016 |
Product Code |
LEI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Revised labeling process of printing labels on a single sheet label stock, per device. |
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