|
Device | LINX REFLUX MANAGEMENT SYSTEM |
Generic Name | IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX |
Applicant | TORAX MEDICAL 4545 Creek Rd Cincinnati, OH 45242 |
PMA Number | P100049 |
Date Received | 12/30/2010 |
Decision Date | 03/22/2012 |
Product Code |
LEI |
Docket Number | 12M-0893 |
Notice Date | 08/14/2012 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT00776997
|
Expedited Review Granted? | No |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE LINX REFLUX MANAGEMENT SYSTEM. THIS DEVICE IS INDICATED FOR PATIENTS DIAGNOSED WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD) AS DEFINED BY ABNORMAL PH TESTING, AND WHO CONTINUE TO HAVE CHRONIC GERD SYMPTOMS DESPITE MAXIMUM THERAPY FOR THE TREATMENT OF REFLUX. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S018 S017 S016 S001 S002 S003 S004 S008 S009 S010 S011 S012 S013 S014 S015 S005 S006 S007 S019 S023 S027 S028 S021 S020 S024 S022 S026 S025 S034 S033 S030 S031 S032 S029 S035 S036 S037 |