|
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 | S029 |
Date Received | 01/12/2021 |
Decision Date | 08/26/2022 |
Product Code |
LEI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the qualification of a new supplier to manufacture the washer, bead case-female, bead case-male and clasp case. |