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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 | S019 |
Date Received | 12/15/2016 |
Decision Date | 01/12/2017 |
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 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. |