|
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 | S027 |
Date Received | 09/17/2019 |
Decision Date | 06/29/2020 |
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 adding a second Hardwell Controlled Environmental Area (CEA). |