|
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 | S009 |
Date Received | 05/15/2014 |
Decision Date | 06/11/2014 |
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 INTRODUCTION OF NEW TENSILE TESTERS TO BE USED DURING LINX DEVICE MANUFACTURING. |